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Due to significant risks of cancer recurrence and progression, and limited options after intravesical Bacillus Calmette Guerin (BCG) therapy, there is a critical unmet need to identify novel treatments for those patients with BCG-unresponsive bladder cancer. There is active investigation of immunotherapies which provide both biologic and clinical rationales for indoleamine-2,3- dioxygenase inhibitors in salvage therapy for non-muscle invasive bladder cancer.

Due to the high rate of recurrence and progression in patients with high risk nonmuscle invasive bladder cancer, there is an important unmet need to identify new therapies. This is particularly true for patients with recurrence after optimal intravesical bacillus Calmette-Guérin therapy, who are classified as having bacillus Calmette-Guérin unresponsive disease.The PubMedWe provide a summary of the currently available immunotherapy options for patients with bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer, and discuss planned and ongoing research of potential targeted agents and immunotherapy based combination regimens.There is a clear biological and clinical rationale for the continued evaluation of immune based therapies in the setting of bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer. Data from early phase trials with novel immunotherapies targeting multiple immune related pathways have emerged, which support additional studies to assess the benefits of immune checkpoint inhibitors and other immunotherapy based regimens for patients with bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer.

TPS493 Background: Immune checkpoint inhibitors, including nivo (anti–PD-1), have demonstrated favorable tolerability and efficacy profiles, ushering in a new treatment (tx) paradigm for advanced bladder cancer (advBC). However, an unmet need exists for new effective tx options in earlier stages of disease, specifically for patients (pts) with BCG-unresponsive, high-risk NMIBC. Increased IDO and PD-L1 expression in NMIBC tumors (Inman, et al. Cancer 2007; Hudolin, et al. Anticancer Res 2017), support the combination of anti–PD-1 and IDO1 inhibition in NMIBC. BMS-986205, a selective, potent, once-daily IDO1 inhibitor that works early in the IDO1 pathway, has demonstrated clinical activity in combination with nivo in pts with immunotherapy-naive advBC who received ≥ 1 prior line of therapy (objective response rate, 37%; Tabernero, et al. J Clin Oncol 2018;36(suppl) [abstr 4512]). These findings provide a rationale for investigation of nivo + BMS-986205 ± intravesical BCG therapy in BCG-unresponsive high-risk NMIBC. Here we describe a phase 2, randomized, open-label study assessing the safety and efficacy of nivo ± BMS-986205 ± intravesical BCG in pts with BCG-unresponsive, high-risk NMIBC. Methods: Pts aged ≥ 18 years with BCG-unresponsive (per February 2018 FDA guidance), high-risk NMIBC, defined as carcinoma-in-situ (CIS) with or without papillary component, any T1, or Ta high-grade lesions, will be enrolled. Pts must have urothelial carcinoma as the predominant histological component (>50%). Key exclusion criteria include locally advanced or metastatic BC, upper urinary tract disease within 2 years, prostatic urethral disease within 1 year, and prior immunotherapy. Using a novel adaptive-type design, pts will be randomized to 1 of 4 tx arms with nivo ± BMS-986205 ± BCG. Primary endpoints include proportion of pts with CIS with complete response (CR), duration of CR in pts with CIS, and event-free survival for all pts without CIS. Secondary endpoints are progression-free survival and safety. This global study in 13 countries is underway, with a target enrollment of 436 pts. ( Clinical trial information: NCT03519256.

Introduction: Nivolumab monotherapy has already shown efficacy and safety in the open-label, single-arm, phase II CheckMate 275 trial (objective response rate [ORR], 19.6%). Here, we report updated results with a minimum follow-up of 21.3 months together with additional exploratory biomarker analyses. Methods: Patients received nivolumab 3 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was confirmed ORR by blinded independent review committee (per Response Evaluation Criteria in Solid Tumors v.1.1). Secondary endpoints included progression-free survival (PFS) and overall survival (OS). ORR was further examined by the duration of response (DoR) and time to response. Outcomes were evaluated in all patients and by tumor cell programmed death-1 ligand 1 (PD-L1) expression (cutoff ≥1% by Dako immunohistochemical staining). Myeloid-derived suppressor cells (MDSCs), defined as Lin− CD14+ HLA-DR-low/negative monocytic myeloid cells, were measured by flow cytometry in the circulation at baseline, and archival pretreatment biopsies were assessed for interferon gamma (IFN-γ) gene expression signature to assess associations with OS. Results: There were 270 treated patients. Median follow-up was 24.5 months. ORR was 20.4% for all treated patients. There were nine additional complete responses (CRs) since results with median follow-up of 11.5 months were reported (17; 6.3%). Of the 55 responders, 72.7% had DoR ≥6 months, 54.5% had DoR ≥12 months, and 30.9% had an ongoing response. Median (95% confidence interval [CI]) DoR for all treated patients was 17.7 (11.5-22.0) months. Median (95% CI) PFS and OS were 1.9 (1.9-2.3) and 8.6 (6.1-11.3) months, respectively. OS benefit was observed across tumor PD-L1 expression levels. The 1-year and 2-year OS rates (95% CI) were 40.3% (34.4-46.2) and 29.4% (23.9-35.1), respectively. The most common any-grade treatment-related adverse events were fatigue (18.1%), diarrhea (12.2%), pruritus (11.5%), and decreased appetite (9.3%). Lower vs higher baseline MDSCs were associated with longer OS in all patients and independent of tumor PD-L1 expression ( Conclusions: In this updated analysis of CheckMate 275, durable efficacy was observed with additional CRs since the previous report. No new safety signals were observed. A combination of immune-associated tumor and circulating biomarkers (as defined in this study) may identify patients with particularly favorable outcomes with nivolumab. Citation Format: Padmanee Sharma, Ari Baron, Andrea Necchi, Elizabeth R. Plimack, Sumanta K. Pal, Jens Bedke, Jose A. Arranz, Daniel Vaena, Marc-Oliver Grimm, Sergio Bracarda, Margitta Retz, Arlene Siefker-Radtke, Chikara Ohyama, Gary Grossfeld, Haolan Lu, Abdel Saci, Hao Tang, Matthew D. Galsky. Nivolumab monotherapy in patients with advanced platinum-resistant urothelial carcinoma: Efficacy and safety update and association between biomarkers and overall survival in CheckMate 275 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr CT178.

Background Adult perineal soft tissue sarcomas are rare. Fewer than 30 cases have been reported, and all were diagnosed after surgical resection by histologic examination. Below we report a case in which the diagnosis was established preoperatively by fine needle aspiration (FNA). Case A 27-year-old man presented with a firm, midline, perineal mass. Magnetic resonance imaging showed a 3-cm, enhancing mass that was considered neoplastic. FNA biopsy, followed by cytologic examination, revealed moderately cellular aspirates composed of discohesive, small, blue cells with scant cytoplasm, high nuclear/cytoplasmic ratios and pleomorphic nuclei with irregular nuclear contours; uniform, hyperchromatic chromatin; and occasional mitotic figures. Frequent naked nuclei and scattered cells with more abundant, dense cytoplasm and eccentric nuclei were also noted. The diagnosis of rhahdomyosarconia was favored on FNA and was corroborated by immunohistochemical stains for desmin, myogenin and CD 56. Upon surgical resection, the diagnosis of alveolar rhabdomyosarcoma was confirmed histologically and immunophenotypically. Conclusion FNA is a useful tool in diagnosing soft tissue lesions of the perineum, including rare primary tumors, such as adult rhabdomyosarcoma. In this case, early identification avoided incisional biopsy and directed appropriate extirpative surgery and reconstruction considerations.

Optimal management and clinical outcome of bladder cancer in renal transplant recipients are not well-defined. We analyzed single institution treatment strategies and outcomes of these patients.We retrospectively reviewed the University of California, San Francisco transplant database which contains information on 6,288 renal transplants performed between 1964 and 2002. The United Network for Organ Sharing database and Israel Penn International Transplant Tumor Registry were also queried to characterize the global nature of bladder cancer in renal transplant recipients.The United Network for Organ Sharing database (1986 to 2001) contained information on 31 patients who were found to have bladder cancer (0.024% prevalence) and the Israel Penn International Transplant Tumor Registry (1967 to 2001) contained information on 135 patients representing 0.84% of all reported malignancies. We identified 7 renal transplant recipients with bladder cancer at our institution. Invasive transitional cell carcinoma developed in 5 patients at a median of 2.8 years after transplant. Three patients underwent uncomplicated radical cystectomy and preservation of the renal allograft. Overall survival at 48 months was 60%.Bladder cancer after renal transplantation is not common. For patients who present with invasive disease, traditional extirpative surgery should be considered. Moreover, the allograft is rarely the source of transitional cell carcinoma and can be preserved. In our experience the cancer and urinary outcomes compare favorably with nontransplant patient outcomes after treatment.

The purpose of The Cancer and Leukemia Group B (CALGB) 90203 trial is to determine which of 2 treatment strategies is superior in treating men with high-risk, clinically localized adenocarcinoma of the prostate (stage T1 to T3a NX M0), defined as a predicted probabilityor =60% of remaining free from disease recurrence for 5 years after surgery. Patients with aor =10-year life expectancy will be randomized to either radical prostatectomy (RP) alone versus estramustine and docetaxel before RP. Participants will be excluded if they have received prior therapy for prostate cancer (except transurethral resection of the prostate) or are judged not to be appropriate candidates for RP. Eligible patients will be stratified according to their predicted probability of remaining free from disease recurrence at 5 years after surgery (0% to 20%, 21% to 40%, and 41% to 60%) and randomized. Neoadjuvant chemotherapy will be 6 cycles (1 cycle = 21 days) of estramustine (280 mg tid, days 1 to 5) and docetaxel (70 mg/m2 on day 2). Warfarin (2 mg/day orally) will be given for prophylaxis against deep venous thrombosis. Bilateral pelvic lymph node dissection and RP will be performed within 60 days of registration/randomization for men randomized to the surgery-alone arm. For men randomized to receive preoperative chemotherapy, the surgical procedure will be performed within 60 days of completion of chemotherapy. Patients will be monitored with history review, physical examination, and serum prostate-specific antigen (PSA) levels every 3 months for the first 3 years after surgery, every 6 months for the next 3 years, and annually thereafter. Biochemical disease recurrence will be defined as a serum PSA level0.4 ng/mL on 2 consecutive occasionsor =3 months apart after RP. The time of biochemical failure is measured from the date of randomization to the time of the first PSA level0.4 ng/mL that is confirmed on the second serial PSA. The primary study end point is to determine if early systemic treatment with neoadjuvant estramustine and docetaxel before RP in patients with high-risk prostate cancer will decrease 5-year recurrence rates when compared with RP alone. Secondary outcomes will include (1) the safety and tolerability of neoadjuvant estramustine and docetaxel before RP; (2) the impact of this neoadjuvant strategy on pathologic tumor stage, including lymph node and surgical margin status; (3) time to clinically apparent disease recurrence; and (4) overall survival. The impact of RP with and without neoadjuvant estramustine and docetaxel on the patient's quality of life from pretreatment through year 3 will be assessed. Frozen prostate tissue will be obtained from men undergoing prostatectomy who are enrolled in either the treatment or control arms of the trial. These samples will be analyzed for their RNA expression patterns in order to build outcome prediction models. Furthermore, using array-based methods of expression analysis, the sensitivity to chemotherapeutic agents and response to chemotherapy may likewise be predicted. The trial will enroll approximately 700 men during a 48-month period. Patients will be observed for 84 months after study closure. The power to detect a 36% decrease in 5-year recurrence rates is 90%.

To examine the effect of a patient's educational level on treatment selection for patients with newly diagnosed prostate cancer. A patient's educational level may impact a patient's understanding and perception of the risks and benefits of the treatment options for prostate cancer.We examined 3484 patients in CaPSURE with prostate cancer between 1992 and 2001. Chi-square and multinomial logistic regression analyses were performed to determine the role of education level in primary treatment received relative to other pretreatment predictors (age, race, insurance status, prostate cancer risk, comorbidity). Prostate cancer risk stratification was determined by serum prostate-specific antigen level and tumor stage and grade.The mean patient age was 67.7 +/- 8.3 years, and the mean prostate-specific antigen level was 13.0 +/- 18.7 ng/mL. Of the 3484 patients, 16.7% had less than a high school education, 27.0% had completed high school or technical school, 19.5% had had some college, 18.0% had graduated from college, and 18.6% had had some graduate education. In bivariate analysis, the factors predictive of treatment selection were patient age, race, education, insurance status, risk group, and patient comorbidity (all P0.001). In multinomial regression analysis, the factors predicting treatment received were age, race, cancer risk group, and comorbidity. For patients older than 75 years, those with a higher education level received more aggressive treatment (radiotherapy versus hormonal therapy) than did those with less education.Patient age, race, cancer risk group, comorbidity, and, for men older than 75 years, education level are the factors predictive of the primary treatment received by men with newly diagnosed prostate cancer.

We measured the impact brachytherapy monotherapy (BMT) has on general and disease specific health related quality of life (HRQOL) compared to patients treated with radical prostatectomy (RP).We studied 419 men with newly diagnosed prostate cancer who enrolled in CaPSURE (Cancer of the Prostate Strategic Urological Research Endeavor) data base whose primary treatment was brachytherapy monotherapy (92) or radical prostatectomy (327). The validated RAND 36-Item Health Survey and the UCLA Prostate Cancer Index were used to measure HRQOL before treatment and at 6-month intervals during the first 2 years after treatment.Patients treated with BMT or RP did not differ greatly in general HRQOL after treatment. Both treatment groups showed early functional impairment in most general domains with scores returning to or approaching baseline in most domains 18 to 24 months after treatment. Patients treated with BMT had significantly higher urinary function scores at 0 to 6 months after treatment (84.5, SD 18.7) than patients treated with RP (63.3, SD 26.6). Urinary bother scores at 0 to 6 months after treatment were not significantly different between patients treated with BMT (67.7, SD 31.2) and those treated with RP (67.4, SD 29.1). Both treatment groups had decreases in sexual function that did not return to pretreatment levels.Overall BMT and RP are well tolerated procedures that cause mild changes in general HRQOL. Disease specific HRQOL patterns are different in patients treated with BMT or RP. Baseline and serial HRQOL measurements after treatment can provide valuable information regarding expected quality of life outcome after treatment for localized prostate cancer.

Purpose: Previous studies have shown that patients with clinical stage T2c-T3 prostate cancer, serum prostate specific antigen (PSA) at diagnosis greater than 20 ng./ml. or a biopsy Gleason score of 8 to 10 are at high risk for disease recurrence after radical prostatectomy. We determined the most important pretreatment predictors of disease recurrence in this high risk population.Materials and Methods: We identified 547 patients with high risk prostate cancer who underwent radical prostatectomy at University of California, San Francisco or as part of the Cancer of the Prostate Strategic Urological Research Endeavor data base, a longitudinal disease registry of patients with prostate cancer. High risk disease was defined as 1992 American Joint Committee on Cancer clinical stage T2c-T3 disease in 411 patients, serum PSA at diagnosis greater than 20 ng./ml. in 124 and/or biopsy Gleason score 8 to 10 in 114. Disease recurrence was defined as PSA 0.2 ng./ml. or greater on 2 consecutive occasions after...

Purpose: Prostate cancer incidence and mortality are higher in black than in white American men. We determined whether ethnicity is an independent predictor of disease recurrence in men undergoing radical prostatectomy.Materials and Methods: We studied 1,468 patients who underwent radical prostatectomy at the University of California, San Francisco or as part of the Cancer of the Prostate Strategic Urological Research Endeavor database, a longitudinal disease registry of patients with prostate cancer. Preoperative characteristics, including age, race, prostate specific antigen (PSA) at diagnosis, clinical T stage, biopsy Gleason score and percent positive prostate biopsies at diagnosis were determined in each patient. Disease recurrence was defined as PSA 0.2 ng./ml. or greater on 2 consecutive occasions after radical prostatectomy or second cancer treatment at least 6 months after surgery. Cox proportional hazards analysis was performed to determine independent predictors of time to disease recur...

Purpose: Prostate cancer can be associated with anxiety, depression and fears of recurrence and side effects of treatment. Support groups may help meet the needs of patients with cancer by providing treatment information and emotional support. We describe men in prostate cancer support groups and compare them to a national registry.Methods and Methods: Men attending prostate cancer support groups in the San Francisco Bay area completed a questionnaire including sociodemographic and clinical characteristics, health related quality of life items, satisfaction with treatment, relief of prostate cancer symptoms and bother from perceived side effects of treatment. Patients in support groups were compared to men enrolled in a national prostate cancer registry (Cancer of the Prostate Strategic Urological Research Endeavor).Results: Men attending support groups had higher annual income and education levels, lower median serum prostate specific antigen and higher cancer grades than men in Cancer of the Pro...

The diagnosis of early-stage prostate cancer cases creates dilemmas for many men diagnosed with the disease each year. Treatment interventions are all associated with significant treatment morbidity, including impotence and incontinence. The basic concept behind patient preferences, or utilities, is to ask patients to make judgments about the value of particular health outcomes. Several preference-based instruments are available, including the visual analog rating scale, the time trade-off utility assessment, and the standard gamble. These assessments result in scores or weights assigned to different health states. From the perspective of the patient with prostate cancer, the treatment that produces optimal outcomes will depend on the relative importance of several domains, which may include pain, urinary functioning, sexual functioning, and general physical health. Patients with similar diagnoses and overlapping clinical characteristics may have markedly different preferences for treatment outcomes.

Purpose: Secondary cancer treatment is common after definitive local therapy for prostate cancer and it may be an indicator of the efficacy and cost of primary local treatment. We determined predictors of secondary cancer treatment in patients initially treated with radical prostatectomy or external beam radiation.Materials and Methods: We examined 2,336 patients in Cancer of the Prostate Strategic Urologic Research Endeavor, a longitudinal registry of patients with prostate cancer, who underwent initial treatment with radical prostatectomy (1,744) or external beam radiation (592). Patients had at least 1 month of followup and all pretreatment information was available. The percent of patients receiving secondary cancer treatment, time to secondary treatment and type of secondary treatment delivered was determined. Multivariate analysis was done to determine independent predictors of secondary cancer treatment. In patients initially treated with prostatectomy a similar analysis was performed to identify p...

Purpose: Previous investigators have reported widespread overuse of imaging tests for staging clinically localized prostate cancer. In this study imaging test utilization rates were analyzed in a contemporary group of patients, and clinical and demographic predictors of testing were identified. Materials and Methods: Data were abstracted from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a longitudinal registry of men with various stages of prostate cancer. A total of 4,966 men met study inclusion criteria of available treatment and staging data. The rates of computerized tomography, magnetic resonance imaging and bone scans performed between the dates of diagnosis and primary treatment were analyzed in patients at 3 levels of clinical risk based on serum prostate specific antigen, Gleason sum and T stage. Time trends in test utilization were analyzed by linear regression. Contemporary rates were compared with those identified in a previous analysis of an earlier CaPSURE cohort. Demographic and clinical predictors of utilization were identified using generalized linear model analysis. Results: Since June 1997, the overall use of staging tests has decreased 63%, 25.9% and 11.4% in patients at low, intermediate and high risk, respectively. The most precipitous decrease was noted for bone scan but the use of cross-sectional imaging also decreased in all groups. Utilization rates were lower in 2001 than in any other year studied in CaPSURE. Conclusions: The rates of testing decreased significantly in all risk groups. However, in the absence of established clinical practice guidelines many patients at low and intermediate risk continue to undergo unnecessary testing, while a growing number of those at high risk are proceeding to treatment without previous imaging.

Purpose: Understanding the potential consequences of racial differences in prostate cancer outcomes, from survival rates to quality of life considerations, is important for the clinician and patient. We examined demographic, clinical and health related quality of life data comparing black with white patients just after treatment of prostate cancer and 1 year later.Materials and Methods: We analyzed data on 1,178 patients who were newly diagnosed with prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavor, a national observational database of men recruited from 35 community and academic urology practices throughout the United States. Patient demographics, clinical characteristics and validated health related quality of life questionnaires were reviewed. A total of 958 white and 161 black patients with prostate cancer who completed at least 2 surveys were compared.Results: The black patients were younger, and had lower income and education levels than white patients. Controlling ...

We describe treatment and reconstruction in patients after surgery for extramammary Paget's disease of the penis and scrotum. We also investigated whether this disease causes an increased risk of undiagnosed visceral malignancy.We reviewed the databases at our institution from 1996 to 2000 and identified 6 men 67 to 87 years old (mean age 76). In addition, we reviewed the literature on the clinical and pathological features of this disease.In our 6 patients scrotal involvement was present in 83% and penile extramammary Paget's disease was present in 33%. Each man underwent wide local excision and large skin defects were immediately reconstructed with split-thickness skin grafts. In 1 case extramammary Paget's disease had spread to the superficial inguinal nodes. At a mean followup of 29 months there has been no local recurrence and internal malignancy has not been diagnosed. Our literature review revealed 13 patients with penoscrotal extramammary Paget's disease and visceral malignancy, including 12 (92%) with malignancy of the genitourinary system.Extramammary Paget's disease of the penis and scrotum is a rare disease that can be managed by excision and immediate reconstruction with skin grafting or a local skin flap. Disease may spread to the regional lymph nodes. Although genitourinary cancer may accompany penoscrotal extramammary Paget's disease, an extensive search for cancer of the thorax or abdomen may be unnecessary because only 1 reported case of colon cancer has been associated with penile or scrotal extramammary Paget's disease.

Purpose: Biostatistical models to predict stage or outcome in patients with clinically localized prostate cancer with pretreatment prostate specific antigen (PSA), Gleason sum on biopsy or prostatectomy specimen, clinical or pathological stage and other variables, including ethnicity, have been developed. However, to date models have relied on small subsets from academic centers or military populations that may not be representative. Our study validates and updates a model published previously with the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE, UCSF, Urology Outcomes Research Group and TAP Pharmaceutical Products, Inc.), a large multicenter, community based prostate cancer database and Center for Prostate Disease Research (CPDR), a large military database.Materials and Methods: We validated a biostatistical model that includes pretreatment PSA, highest Gleason sum on prostatectomy specimen, prostatectomy organ confinement status and ethnicity, including white and black patients....

Treatment for prostate cancer has a significant impact on health-related quality of life (HRQOL). We examined HRQOL in a cohort of men receiving androgen deprivation therapy (ADT) and a cohort who opted for surveillance. The cohort consisted of 1178 newly diagnosed patients from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database (a national longitudinal registry of patients with prostate cancer). General and disease-specific HRQOL outcomes were measured with validated instruments (the SF-36 and University of California at Los Angeles [UCLA] Prostate Cancer Index) at study entry and quarterly thereafter. Individuals were grouped by initial treatment: ADT, surveillance, radical prostatectomy, or radiation therapy. There were 106 men who selected surveillance, 167 men receiving ADT, 351 men treated by radical prostatectomy, and 75 men receiving radiation therapy in the first year after diagnosis. Mean age at diagnosis was 73 years of age, with surveillance patients the oldest and radical prostatectomy patients the youngest. Men receiving ADT reported poorer urinary and sexual function and a higher rate of urinary and sexual bother than patients selecting surveillance. ADT and surveillance HRQOL scores remained low (ie, poorer function) in the year after treatment, whereas men undergoing radical prostatectomy showed improvement in these scales. Patients who received ADT had reduced energy, poorer sexual and urinary function, and were more bothered by their urine and sexual function than patients undergoing other treatments, except surveillance. Longer follow-up time after start of ADT and surveillance is needed to discern the impact of comorbidities on HRQOL.

Objectives. To update the cycling characteristics and patterns of treatment in patients receiving intermittent androgen deprivation (IAD) for clinically localized and recurrent prostate cancer. Methods. We report our experience with 61 patients treated with IAD. Thirty-four patients had received no prior treatment, and 27 had developed recurrent disease after previous local therapy. No patient had clinically apparent metastatic disease before the initiation of therapy. The mean and median serum prostate-specific antigen (PSA) level before treatment was 25.3 ng/mL and 16.0 ng/mL, respectively (range 0.5 to 190 ng/mL). For each cycle, androgen deprivation was continued until PSA became undetectable or a nadir level was reached. Patients were then observed without treatment, and therapy was reinstituted after the serum PSA value reached a predetermined level. Patients were no longer eligible to cycle off treatment when their serum PSA increased despite ongoing androgen deprivation or if any objective evidence of disease progression was present on imaging studies. Results. Follow-up ranged from 7 to 60 months (mean 30) from the start of treatment. Patients received from one to five treatment cycles (median two), with a median cycle length of 14 months. The median nadir serum PSA level during androgen deprivation was 0.01 ng/mL and was reached within an average of 6 months (range 4 to 9) after beginning treatment. Patients spent an average of 45% of the time not receiving therapy, but the time off therapy decreased as the number of treatment cycles increased. Five patients (8.1%) demonstrated progressive disease, with a median time to progression of 48 months. When examining the cycling characteristics of these patients, no consistent pattern of failure emerged. Conclusions. IAD appears to be a viable treatment option in select patients with localized prostate cancer. With each consecutive cycle, the amount of time the patient was not receiving therapy decreased, despite achieving a low nadir PSA. Longer follow-up with more patients failing IAD will be required before clear patterns of failure emerge in these patients.

Purpose: We used clinical variables to predict prostate cancer detection on re-biopsy among patients diagnosed with high grade prostatic intraepithelial neoplasia (PIN) or atypia on initial prostate biopsy.Materials and Methods: A total of 45 men with atypia and 43 with high grade PIN were eligible for our study. Clinical variables were tested with univariate and multivariate logistic regression to predict who would have cancer on re-biopsy. We also calculated the odds of detecting cancer with various repeat sampling strategies and determined whether the location of initial atypia or high grade PIN is correlated to that of cancer on re-biopsy.Results: Of the patients in the atypia and high grade PIN groups 51% had cancer on re-biopsy. Cancer was diagnosed significantly earlier in the high grade PIN than in the atypia cohort (average 7.5 versus 22.9 months, respectively, p = 0.005). Multivariate logistic modeling showed that digital rectal examination and patient age were independent predictors of cancer i...

Purpose: We determined the prevalence of under staging and under grading in contemporary patients undergoing radical prostatectomy in academic and community based urology practices, and defined important predictors of under staging in this population.Materials and Methods: We compared clinical T stage and biopsy Gleason score with pathological T stage and prostatectomy Gleason score in 1,313 patients enrolled in the Cancer of the Prostate Strategic Urologic Research Endeavor database, a longitudinal registry of patients with prostate cancer, who underwent radical prostatectomy, including 53% since 1995. Under grading was determined for the primary and secondary Gleason patterns and defined as a biopsy Gleason pattern of 1 to 3 that became pathological Gleason pattern 4 or 5. Under staging was defined as a clinically organ confined tumor that was extraprostatic stages pT3 to 4 or N+ at radical prostatectomy. Univariate and multivariate analysis was performed to determine important risk factors for under st...

Objectives. To define patterns of treatment among contemporary patients undergoing radical prostatectomy, interstitial radiation, and external beam radiation for prostate cancer. Methods. We analyzed 291 consecutive patients (Stage T1-T3NXM0) who underwent definitive local treatment for prostate cancer with radical prostatectomy, interstitial seed implantation, or external beam radiation. Patients were stratified into three risk groups based on clinical T stage, serum prostate-specific antigen level at diagnosis, and biopsy Gleason score. The frequency of additional treatments, including androgen deprivation and external beam radiation, given within 3 months of initial local therapy was assessed. Patterns of care were compared and adjusted for risk. Results. Of the 291 patients, 107 (36.8%) underwent radical prostatectomy, 94 (32.3%) underwent interstitial seed implantation, and 90 (30.9%) underwent external beam radiation. Use of combination therapy differed significantly according to the type of initial local treatment and risk category. No patient in the low-risk group received combination therapy. For patients in the intermediate and high-risk groups, the frequency of combination therapy was significantly lower in the radical prostatectomy group when compared with either the interstitial seed implantation (P

Purpose: We determined the demographic and clinical profile of men who elect surveillance as the initial management of prostate cancer as well as the incidence and predictors of secondary treatment of these patients.Materials and Methods: The Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE) is a national disease registry of patients with various stages and treatments of prostate cancer. Using this database of 4,458 men we identified 329 (8.2%) who elected surveillance as the initial management of prostate cancer. Patients choosing watchful waiting were compared to other CaPSURE participants using the chi-square test. The likelihood of treatment initiation in the watchful waiting group was calculated using the Kaplan-Meier method. After adjusting for patient age, race, prostate specific antigen (PSA) at diagnosis, clinical T stage and total Gleason score the Cox proportional hazards regression model was used to determine significant predictors of treatment initiation.Results: Compare...

Purpose:: We determined the impact of positive surgical margins on prostate specific antigen (PSA) recurrence and secondary treatment in patients who underwent radical prostatectomy as definitive local treatment for prostate cancer.Materials and Methods:: We reviewed the pathology reports of 1,383 patients in the CaPSURE * *Technology Assessment Group, San Francisco, California. database, a longitudinal disease registry of men with prostate cancer, who underwent radical prostatectomy as definitive local treatment. Pathological stage, Gleason score, and the number and location of any positive surgical margins were determined in each patient. PSA recurrence was defined as PSA 0.2 ng./ml. or greater on 2 consecutive occasions after radical prostatectomy. Secondary cancer treatment consisted of radiation or androgen deprivation after radical prostatectomy. Adjuvant and nonadjuvant secondary treatment was given within and more than 6 months after radical prostatectomy, respectively. Kaplan-Meier event rates of...

The term benign prostatic hyperplasia has traditionally been used to describe a constellation of obstructive and irritative voiding symptoms that occur in men as they age. Such symptomatology may be due to a variety of causes, including prostatic enlargement. Thus, the term lower urinary tract symptoms has replaced BPH to describe this symptom complex. The evaluation and treatment of LUTS continues to be a significant part of urology practice in the United States, as well as a significant component of medical resource utilization. Currently, indication for treatment in patients with LUTS is most often based on subjective measurements of symptom severity and bother. Consequently, imaging does not play a major role in the evaluation of such patients. Recent data suggest that the size of the prostate gland may predict which patients with LUTS will develop progressive symptoms and complications. Moreover, both prostate size and the histologic composition of BPH may help to select patients for specific treatment options. Thus, radiologic imaging may eventually play a larger role in the diagnosis and treatment of LUTS in the future. After review of the literature, it appears that routine upper urinary tract imaging in patients with LUTS or BPH is not warranted. Selective use of such imaging tests in patients with BPH and either hematuria, laboratory evidence of renal insufficiency (elevated BUN or creatinine), or a history of urinary tract infection, urolithiasis, previous urinary tract surgery, or congenital or acquired renal disease remains indicated. Local imaging of the prostate can be performed with either MR imaging or TRUS. Although MR imaging provides excellent resolution of internal prostatic anatomy, information with respect to the ratio of glandular to stromal tissue in the prostate, and an accurate estimate of prostate volume, its use in patients with BPH is limited by its high cost and limited availability. In contrast, TRUS remains an important tool in the evaluation of patients with prostatic disease. Similar to MR imaging, TRUS provides excellent images of internal prostatic anatomy and an accurate estimate of prostate volume prior to treatment. In addition, this imaging modality is noninvasive, cost-efficient, easily adapted to office use, and able to provide guidance for transrectal prostate biopsy.

Purpose: We analyze biopsy and prostate specific antigen (PSA) results following cryosurgery for patients with clinically localized prostate cancer.Materials and Methods: A total of 176 patients underwent 207 cryosurgical procedures for clinically localized (stages T1 to T4) prostate cancer using a multiprobe cryosurgical device. Cancer stage was T1 in 8.7%, T2 in 30%, T3 in 59% and T4 in 2.3% of the 176 patients. Neoadjuvant androgen deprivation was delivered to 101 patients (57%). End points used to determine efficacy of the procedure included analysis of posttreatment serum PSA characteristics (nadir and nonrising status) and biopsy results (absence of cancer). Cryosurgery was considered successful if PSA reached a nadir of less than 0.5 ng./ml. and did not increase by more than 0.2 ng./ml. on 2 consecutive occasions. Mean followup for the entire group was 30.8 months, with 122 patients (60%) followed for 24 or more months and 75 (36%) followed for 36 or more months.Results: Serial PSA data was...

Most human prostate tumors are adenocarcinomas which arise from the epithelial cells that line the glands and ducts of the prostate. Consequently, the malignant epithelial cell, or more specifically genetic damage suffered by that malignant epithelial cell, has been the major focus of prostate cancer research to date. There is, however, increasing evidence to suggest that alterations in the stromal microenvironment associated with a malignant epithelium may be necessary for progression of carcinogenesis. We have recently hypothesized that interactions between the stroma and epithelium become altered as a result of genetic damage to the prostatic epithelial cell. During prostatic carcinogenesis, this abnormal signaling may lead to changes in both the prostatic epithelium and smooth muscle with concomitant loss of growth control. In this way, both a malignant epithelium and an abnormal or ‘tumor stroma’ evolve. The purpose of this article is to describe interactions between the stroma and epithelium of the normal prostate, and then to summarize evidence suggesting that stromal cells derived from benign versus malignant sources may exert differential effects on epithelial cell growth and differentiation. Acknowledgements This work was supported by NIH grants DK52721, CA 59831, DK 45861, CA 64872, DK 52708 and DK 47517, and by an AFUD/Pfizer USPG Research Scholarship to GDG.

We describe secular trends in the use of imaging tests to stage prostate cancer, evaluate the impact of selected clinical factors on test use and compare physician actual use with recommendations in recently published literature.This retrospective nonrandomized analysis of a longitudinal disease registry enrolled 3,557 men diagnosed with prostate cancer between 1989 and 1997 at 29 urology practices throughout the United States. Using logistic regression the odds of performing pelvic computerized tomography (CT), pelvic magnetic resonance imaging (MRI), bone scan and excretory urogram were determined annually from 1989 to 1997. The frequency of test use was compared with recommendations from a recent urology literature synopsis.Use of MRI, CT, bone scan and excretory urogram was unchanged from 1989 to 1997. Compared to recent findings in the clinical literature bone scan, CT and MRI were used too frequently in patients at low risk for metastatic disease.Urologists may be overusing bone scan, CT and MRI to stage tumors in patients with a low risk of advanced prostate cancer. Further studies are needed to assess the relationship between individual staging strategies and clinical outcomes.

Purpose: We determine which clinical characteristics correlate with a successful outcome following external beam radiation for the management of biopsy proved, locally recurrent prostate cancer after radical prostatectomy.Materials and Methods: The clinical records of 34 patients who were treated at our institution with external beam radiation for biopsy proved local disease recurrence after radical prostatectomy were reviewed. Mean followup was 77.9 months after radical prostatectomy and 38.3 months after radiotherapy. Preoperative, postoperative and pathological characteristics were examined for the ability to predict failure following radiotherapy.Results: Of the 34 patients 9 (26%) exhibited persistently low and stable serum prostate specific antigen (PSA) (less than 0.5 ng./ml.), while 7 (21%) had an undetectable serum PSA (less than 0.1 ng./ml.) during followup. These 16 patients were considered to be successfully treated by radiation and in the remaining 18 (53%) radiation was considered to...

Asymptomatic microscopic hematuria continues to be a common cause for urologic referral. Depending on the population under investigation, the condition is reported in 0.2% to 21.1% of subjects. Many possible etiologies exist for the presence of asymptomatic microscopic hematuria, ranging from insignificant lesions to potentially life-threatening lesions that may require urgent treatment. A cause for asymptomatic microscopic hematuria can be determined in 32% to 100% of patients undergoing a full urologic evaluation, with 3.4% to 56% of these patients having either moderately or highly significant lesions at the time of diagnosis. Consequently, full urologic evaluation is warranted in the majority of patients referred to a urologist with asymptomatic microscopic hematuria. In patients in whom no diagnosis is reached after initial evaluation, follow-up is necessary, although the extent and timing of such follow-up have not been adequately investigated. The ultimate goal of evaluating any patient with asymptomatic microscopic hematuria is the discovery of a significant lesion at an early stage when it is amenable to curative therapy and prior to that lesion causing significant morbidity. No randomized, prospective studies have compared the outcomes of patients with asymptomatic microscopic hematuria undergoing full evaluation with those of patients undergoing surveillance only. The data obtained in high-risk groups undergoing urinary dipstick screening for bladder cancer suggest that the bladder tumors discovered when evaluating all patients with asymptomatic microscopic hematuria may be more amenable to treatment than those normally encountered, thereby possibly reducing the mortality and morbidity associated with bladder cancer in these patients. These findings support the evaluation of patients with asymptomatic microscopic hematuria in a cost-conscious medical environment.

Purpose: We compare secondary cancer treatment use in patients who underwent definitive local treatment for prostate cancer.Materials and Methods: The rate of second cancer treatment was determined in patients who underwent radical prostatectomy (1,254), radiotherapy (499) or cryosurgery (141) using data from the CaPSURE database, a longitudinal disease registry of patients with prostate cancer. Second treatments started within 3 months after initial treatment were defined as adjuvant and those started more than 3 months were defined as nonadjuvant. Using a parametric regression model of survival analysis, second treatment rates were adjusted for differences in clinical and demographic characteristics, and duration of followup among groups.Results: Of the patients 4% received a second adjuvant treatment and 17% received a second nonadjuvant treatment within 3 years of initial therapy. Adjusted rates of nonadjuvant second treatment were lowest after radical prostatectomy, and 34 and 88% higher afte...

Purpose: We provide a contemporary review of bladder tumor markers and summarize their role as prognostic indicators.Materials and Methods: A comprehensive review of the literature on prognostic markers for transitional cell carcinoma of the bladder was performed.Results: Intense research efforts are being made to identify and characterize better various bladder cancers and their true biological potential. The need to predict which superficial tumors will recur or progress and which invasive tumors will metastasize has led to the identification of a variety of potential prognostic markers. Blood group antigens, tumor associated antigens, proliferating antigens, oncogenes, peptide growth factors and their receptors, cell adhesion molecules, tumor angiogenesis and angiogenesis inhibitors, and cell cycle regulatory proteins have recently been identified. The potential clinical applications of these tumor markers are under active investigation. Recent attention has focused on which tumor markers may p...

Patients newly diagnosed with testis cancer can now expect excellent results with respect to long-term, disease-free survival after treatment. Given the young age of presentation for many of these patients, the long-term consequences of curing testis cancer have become a major concern. Surgery, radiation, and chemotherapy for testis cancer have all been associated with potential long-term side-effects. Consequently, new treatment regimens have been directed toward minimizing these possible side-effects while at the same time maintaining high cure rates (i.e., limiting the size of radiation fields, decreasing the number of chemotherapy cycles, eliminating bleomycin). Patients and physicians must be made aware of the potential adverse side effects of treatment for testis cancer. At the present time, however, it appears that the beneficial effects of such treatment, with respect to overall and disease-free survival, far outweigh the limited probability of persistent treatment-related side effects in patients newly diagnosed with testis cancer.

Objectives. To prospectively evaluate our previously established pathologic risk factors in women undergoing cystectomy for bladder cancer and to determine if these criteria identify appropriate female candidates for orthotopic diversion. Methods. Prospective pathologic evaluation was performed on 71 consecutive female cystectomy specimens removed for primary transitional cell carcinoma of the bladder. The histologic grade, pathologic stage, presence of carcinoma in situ, number, and location of tumors were determined. In addition, final pathologic analysis of the bladder neck and proximal urethra was performed and compared with the intraoperative frozen-section analysis of the distal margin (proximal urethra). Results. Tumor at the bladder neck and proximal urethra was seen in 14 (19%) and 5 (7%) cystectomy specimens, respectively. Bladder neck tumor involvement was found to be the most significant risk factor for tumor involving the urethra (P

We compare the biological phenotype of recurrent prostatic tumors after definitive local therapy (radiation or radical prostatectomy) with that of the same tumors before treatment.Cellular proliferation (Ki-67 labeling index), p53 nuclear reactivity and bcl-2 immunoreactivity were determined in pretreatment and posttreatment tumor specimens from 13 patients with local tumor recurrence following radiation, and in 18 patients with local tumor recurrence following radical prostatectomy.Mean Ki-67 labeling index increased approximately 2-fold in locally recurrent tumors after radiation (10.5 versus 5.6%, p=0.0008) or surgery (6.0 versus 3.2%, p=0.0025) when compared with pretreatment tumors. We noted p53 nuclear reactivity in a significantly higher proportion of recurrences than in pretreatment tumors following radiation (54 versus 8%, p=0.032) and surgery (39 versus 5%, p=0.022). Although bcl-2 immunoreactivity was also seen in a higher proportion of recurrent tumors, this difference did not reach statistical significance for either radiation or surgery.Recurrent tumors following either radiation or surgery differ significantly from the corresponding pretreatment tumors with respect to cellular proliferation and p53 nuclear reactivity.

Horseshoe kidney and retrocaval ureter are two uncommon congenital anomalies of the genitourinary system that have rarely been reported to occur in the same patient. In each case previously reported, the isthmus of the horseshoe was positioned posterior to the inferior vena cava and anterior to the aorta. In no case was the diagnosis of both anomalies made preoperatively. We report a case of simultaneous horseshoe kidney and retrocaval ureter diagnosed by preoperative imaging studies and discuss the diagnostic evaluation and surgical management of this rare entity.

Thrombospondin-1 (TSP) is a 450-KD glycoprotein that was initially discovered in the platelet alpha-granule. It now appears that TSP is intimately involved in the regulation of a variety of cellular functions and cell-to-cell interactions. Recently, it has been demonstrated that TSP functions as a p53-dependent inhibitor of angiogenesis in cultured fibroblasts from Li-Fraumeni patients and therefore may be an important factor involved with tumor invasion and metastasis. It has previously been demonstrated that TSP can be detected in frozen tissue sections by immunohistochemical methods. Our objective in this study was to determine the optimal antigen retrieval (AR) protocol for detection of TSP in formalin-fixed, paraffin-embedded tissue by using tissue sections from patients with invasive transitional cell carcinoma of the bladder. The optimal AR protocol was determined utilizing a variety of heating conditions and antigen retrieval buffers. Our results demonstrate that TSP can be reliably detected in paraffin-embedded tissue by immunohistochemical techniques that utilize AR with high-temperature microwave heating and a low-pH Tris-HCI buffer. The importance of this method is that it allows the reliable detection of TSP in archival tissue. This should facilitate further investigation into TSP's role in the regulation of cellular processes, including its influence on tumor angiogenesis and metastasis.

Purpose: We describe a variation of the ileal conduit that includes a nonrefluxing nipple valve designed to protect the upper urinary tracts.Materials and Methods: A total of 13 patients underwent urinary diversion with the nonrefluxing ileal conduit. The nonrefluxing nipple valve is created by intussuscepting the ileum into the conduit.Results: Followup ranged from 3 to 35 months. No patient demonstrated radiographic deterioration of the upper tracts or a clinically significant increase in serum creatinine level during followup.Conclusions: The nonrefluxing ileal conduit appears to be a viable treatment option in select patients with neurogenic bladder dysfunction.

Purpose: To determine the incidence of occult lymph node metastases in patients with stage pT3NO prostate cancer.Materials and Methods: Lymph nodes from 95 patients with stage pT3NO prostate cancer were analyzed by immunohistochemistry for extrinsic epithelial cells using epithelial-specific monoclonal antibodies. The extrinsic epithelial cells were also tested for prostate specific antigen expression.Results: Occult lymph node metastases were identified in 15 cases (16 percent) and were more frequent in patients with high primary Gleason grade tumors and seminal vesicle invasion (p = 0.03). In all cases the extrinsic cells were of prostate origin based on prostate specific antigen expression.Conclusions: Occult lymph node metastases can be detected in a substantial proportion of patients with stage pT3NO prostate cancer, are associated with known predictors of disease progression, and may be useful in identifying patients at risk for recurrence and progression.

Augmentation enterocystoplasty is the standard treatment for patients with neurogenic bladder who have failed medical management. Our "extraperitoneal" approach involves a small peritoneotomy to obtain the segment of bowel for augmentation, and a standard "clam" enterocystoplasty. We compared operative and postoperative parameters and clinical outcomes of this technique with the standard intraperitoneal technique.We retrospectively reviewed charts of 73 patients with neurogenic voiding dysfunction refractory to medical management who underwent augmentation enterocystoplasty alone or in conjunction with additional procedures. A total of 49 patients underwent extraperitoneal augmentation and 24 patients underwent intraperitoneal augmentation. Operative and postoperative parameters including time of surgery, estimated blood loss, need for blood transfusion, time for return of bowel function, and length of hospital stay were examined. Clinical outcomes including early and late postoperative complications, and continence status were also analyzed.Median follow-up was 2.5 years. Patients in the extraperitoneal group had significantly shorter operative time (3.9 vs. 5.6 h, P0.0001); shorter hospital stay (8.0 vs. 10.5 days, P = 0.009); and shorter time to return of bowel function (3.5 vs. 4.9 days, P = 0.0005). There was no significant difference in complication rates. Postoperative continence was equally improved in both groups. When only patients with no prior abdominal surgery were compared, the findings were analogous: shorter operative time, shorter length of stay, sooner return of bowel function, and no difference in complication rate.The extraperitoneal technique provides an equally effective method of bladder augmentation to the standard technique with easier early postoperative recovery.

Prostate cancer is the most common non-cutaneous malignancy in men and poses a substantial risk to the life and health of patients. Treatment options for patients with prostate cancer are plentiful. Radical prostatectomy is one option that can be performed using several different surgical approaches. It can be performed with limited risk of complications and is likely to be curative in patients with organ-confined disease and those with limited extracapsular extension.

The early diagnosis of prostate cancer has been facilitated by the development of serum prostate-specific antigen (PSA) testing and evolution in transrectal ultrasound-guided biopsy of the prostate. Over a decade has passed since the initial recommendations for systematic sextant sampling of the prostate to increase the accuracy of cancer detection. Subsequently, variations in the number and location of biopsies have been proposed to maximize prostate cancer detection and obtain more complete information regarding tumor grade, tumor volume, and local stage. Although current biopsy strategies provide a wide sampling of the prostate gland, biopsy histology may not be conclusive for either the presence or absence of adenocarcinoma. High-grade prostatic intraepithelial neoplasia (HGPIN) is found in a significant fraction of patients undergoing transrectal prostate biopsies. In this article, we discuss the significance of high-grade prostatic intraepithelial neoplasia and other abnormal histology findings and current evidence addressing the presence of cancer and need for additional prostate biopsies.

BACKGROUND:Recent reports have suggested that growing numbers of patients with localized prostate cancer are receiving androgen deprivation therapy as primary or neoadjuvant treatment, yet sparse clinical evidence supports the use of such treatment except among patients with high-risk or locally advanced disease receiving external beam radiotherapy. We describe national trends in the use of androgen deprivation therapy for localized disease. METHODS:CaPSURE is an observational database of 7195 patients with prostate cancer. This study included 3439 of these patients who were diagnosed since 1989, had clinical staging information available, and were treated with radical prostatectomy, radiation therapy, or primary androgen deprivation therapy (PADT). High-, intermediate-, and low-risk groups were defined by serum prostate-specific antigen level, Gleason score, and clinical tumor stage. Time trends in the use of PADT and neoadjuvant androgen deprivation therapy (NADT) were analyzed. All statistical tests were two-sided. RESULTS:Rates of PADT use rose sharply between 1989 and 2001, from 4.6% (95% confidence interval [CI] = 3.4% to 5.8%) to 14.2% (95% CI = 12.2% to 16.2%), from 8.9% (95% CI = 7.3% to 10.5%) to 19.7% (95% CI = 17.5% to 21.9%), and from 32.8% (95% CI = 29.9% to 35.7%) to 48.2% (95% CI = 45.1% to 51.3%) (all P

To characterize the association between potency and comprehensive sexual function. The accurate assessment of sexual function is critical for the evaluation of outcomes after treatment of prostate cancer. The assessments of potency typically used in this context, however, may be oversimplified.CaPSURE is a large, observational database of men with prostate cancer. Participants complete health-related quality-of-life questionnaires, including the University of California, Los Angeles Prostate Cancer Index, every 6 months after treatment. A total of 5135 men completed at least one questionnaire and did not use medications for erectile function. The men were categorized as potent or impotent based on their ability to have erections and/or intercourse in the prior 4 weeks. Using the remaining questions on the Prostate Cancer Index, sexual function and bother scores were calculated for each group.Of the 5135 men, 27.4% were potent. The mean sexual function scores were 56 and 13 for potent and impotent men, respectively (P0.0001). The corresponding mean bother scores were 62 and 36 (P0.0001). The function scores ranged from 0 to 100 and 0 to 92 among potent and impotent men, respectively, and bother scores from 0 to 100 in both groups. Function was inversely associated with age in both groups, but bother did not change among potent men and ameliorated among impotent men. Individual Prostate Cancer Index questions correlated with potency to a variable extent.Although potent and impotent men have divergent sexual function and bother scores after treatment, the wide range of these scores in both groups denotes a complex picture of sexual function. The simple documentation of potency after treatment provides an insufficient measure of sexual health-related quality of life and should be supplemented with more comprehensive measures.

Prostate cancer is a significant health care problem for American men. It continues to be the most commonly diagnosed malignancy in American men and the second leading cause of cancer deaths (1). In 2002, the American Cancer Society estimated over 189,000 new cases of prostate cancer (2). Based on the yearly incidence of new prostate cancer cases in the United States, it was estimated that more than a half-million transrectal ultrasound —guided prostate biopsies were performed in 2001.

The timing and type of treatment for patients with biochemical disease recurrence after local therapy for prostate cancer remains controversial. This is because of many unresolved issues surrounding the natural history of disease progression in such patients, including the limited ability of clinical measures to accurately define local versus distant disease recurrence. Clinicians generally rely on clinical tumor characteristics, such as tumor stage, grade, and prostate specific antigen (PSA) kinetics after local therapy, to distinguish local from distant recurrence. This determination is important, because patients with local recurrence may be candidates for a second, potentially curative treatment, whereas those with distant recurrence are generally treated with androgen deprivation therapy (ADT). Data from a national disease registry of patients with prostate cancer, the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), suggest that the use of secondary cancer treatment after local therapy for prostate cancer is common. For patients initially treated with radical prostatectomy, secondary treatment appears to be nearly equally divided between postoperative radiation and ADT, whereas >90% of patients receiving a secondary treatment after radiation are treated with ADT. Serum PSA at diagnosis, Gleason score, and type of initial treatment appear to be predictors of secondary treatment use in this setting. Patient age, lymph node status, and margin status appear to be predictors of secondary treatment with ADT or radiation for patients initially treated with radical prostatectomy.

Although once reserved for the management of metastatic prostate cancer, androgen deprivation therapy (ADT) is being used increasingly to treat lower stages of disease. We sought to assess patterns of ADT use in a contemporary cohort of men newly diagnosed with prostate cancer. Men with newly diagnosed prostate cancer who had > or =12 months of follow-up evaluation were identified in a national disease registry of patients with prostate cancer. The patterns of ADT use, both primary and secondary, were characterized and stratified by risk according to prostate-specific antigen levels, clinical stage, and Gleason score. In a cohort of 1485 men, 46% underwent ADT at some point during their treatment: 41% as primary therapy (either sole therapy or neoadjuvant therapy), and 5% as secondary therapy. In all, 50% of men receiving initial ADT had low- or intermediate-risk disease characteristics. Among patients treated with radical prostatectomy and radiation therapy, neoadjuvant ADT was administered in 20% and 48% of patients, respectively. Secondary hormonal manipulation was observed in 5% and 7% of patients treated initially with surgery or radiation, respectively. ADT is commonly used to treat men with prostate cancer. Much of the use of ADT is in men with low- and intermediate-risk disease characteristics. The appropriateness of such therapy requires further study, including its effect, not only on disease endpoints, but also on resource utilization and health-related quality of life.