Search

Objective: To evaluate the risk of postoperative hernia following different approaches of single-port robot-assisted radical prostatectomy (SP-RARP)., Methods: A retrospective review was performed on patients who underwent SP-RARP between February 2019 and December 2022. Demographic and clinical information was collected from the multi-institutional, prospectively-maintained Single-Port Advanced Research Consortium (SPARC) database. Data were analyzed using IBM Statistical Packaging for Social Sciences (SPSS) version 29.0 with descriptive statistics as presented., Results: A total of 1103 patients were identified, consisting of 244 (22.1%), 712 (64.6%), and 147 (13.3%) cases performed via transperitoneal, extraperitoneal (EP), and transvesical (TV) approaches, respectively. During a median follow-up time of 11 months (interquartile range 5.7-17.1 months), only two cases of incisional hernia were reported. Both cases occurred following transperitoneal SP-RARP with one patient requiring surgical repair. There remains no evidence of postoperative hernia following EP and TV SP-RARP at the completion of our review., Conclusion: SP-RARP was associated with low risk for postoperative hernia. The risk was lower following TV and EP SP-RARP where the peritoneum is preserved., Competing Interests: Declaration of Competing Interest Michael Stifelman: Consultant for VTI, performs educational activities for Ethicon, and is on the Scientific Advisory Board for Intuitive. Mutahar Ahmed: Consultant/Advisor at Intuitive, Aminox/Clarix, and VTI. Simone Crivellaro: Consultant for Intuitive. Jihad H. Kaouk: Speaker for Intuitive and Consultant for VTI. All the other authors have no conflict of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To establish a consensus for initial evaluation and follow-up of patients on active surveillance (AS) for T1 renal masses (T1RM)., Methods: A modified Delphi method was used to gather information about AS of T1RM, with a focus on patient selection, timing/type of imaging modality, and triggers for intervention. A consensus panel of Michigan Urological Surgery Improvement Collaborative-affiliated urologists who routinely manage renal masses was formed. Areas of consensus (defined >80% agreement) about T1RM AS were established iteratively via 3 rounds of online questionnaires., Results: Twenty-six Michigan Urological Surgery Improvement Collaborative urologists formed the panel. Consensus was achieved for 321/587 scenarios (54.7%) administered through 124 questions. Life expectancy, age, comorbidity, and renal function were most important for patient selection, with life expectancy ranking first. All tumors <3 cm and all patients with life expectancy <1 year were considered appropriate for AS. Appropriateness also increased with elevated perioperative risk, increasing tumor complexity, and/or declining renal function. Consensus was for multiphasic axial imaging initially (contrast CT for GFR >60 or MRI for GFR >30) with first repeat imaging at 3-6 months and subsequent imaging timing determined by tumor size. Consensus was for chest imaging for tumors >3 cm initially and >5 cm at follow up. Renal biopsy was not felt to be a requirement for entering AS, but useful in several scenarios. Consensus indicated rapid tumor growth as an appropriate trigger for intervention., Conclusion: Our consensus panel was able to achieve areas of consensus to help define a clinically useful and specific roadmap for AS of T1RM and areas for further discussion where consensus was not achieved., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023. Published by Elsevier Inc.)

Objective: To aid in the diagnosis and treatment of patients with metastatic tumor seeding, an exceedingly rare phenomenon following minimally invasive urological surgery, additional case reports are needed., Materials and Methods: We report our experience with patients determined to have peritoneal carcinomatosis following robotic-assisted radical prostatectomy (RARP) and provide a descriptive summary of these unique cases., Results: Five cases of peritoneal carcinomatosis were identified, all of which occurred relatively late-between 8 and 13 years-following RARP. Four of the 5 cases had T3 disease at the time of prostatectomy. 68 Ga-PSMA PET identified peritoneal carcinomatosis in 3 of 5 cases., Conclusion: Certain clinical factors, such as advanced pathologic stage at the time of prostatectomy, may predict risk for carcinomatosis following RARP. Additionally, next-generation imaging modalities, such as PSMA PET, may aid in identifying these metastases and are likely to identify increasing numbers of these patients as next-generation imaging becomes more widely available. Continued documentation and classification of this atypical presentation are needed to improve our understanding and management of this phenomenon., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: We present postprostatectomy pathology results from a series of prostate cancer (Pca) Gleason grade group ≥2 patients who did not have findings suggestive of cancer on preoperative pelvic magnetic resonance imaging (MRI)., Methods: We performed an institutional retrospective study of prostate magnetic resonance imaging (MRI) examinations done from October 2015 to February 2018. We identified patients who underwent prostatectomy for Pca Gleason ≥3 + 4 diagnosed on prostate biopsy with no associated MRI findings suggestive of malignancy and analyzed their postprostatectomy pathologic findings and MRI imaging results., Results: At our institution, 850 men with Pca received MRI between 2015 and 2018, and 156/850 patients received robotic-assisted radical prostatectomy. Thirty-three patients (33/156 = 21%) had negative MRI for PIRAD 3 or greater but had a biopsy showing significant Pca. Their mean (range) age was 62.7 (50-86) years. Their median (interquartile range) PSA, and PSA density were, 4.6 (3.7) ng/mL and 0.12 (0.05) ng/mL/cm 2 , respectively; all not significantly different from patients with visible lesions on MRI who underwent surgery. On post prostatectomy pathology, 27/33 (82%) men had Pca Gleason score 7 or greater. The most common pattern was infiltrative growth with cancer glands intermingling between benign glands., Conclusion: We describe the pathologic and imaging findings in an extensive series of men with clinically significant Pca with no significant lesions on preoperative MRI. Our results support the importance of patient counseling on the risk of missing significant Pca on MRI in isolation from other clinical variables., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To describe and evaluate a risk-stratified triage pathway for inpatient urology consultations during the SARS-CoV-2 (COVID-19) pandemic. This pathway seeks to outline a urology patient care strategy that reduces the transmission risk to both healthcare providers and patients, reduces the healthcare burden, and maintains appropriate patient care., Materials and Methods: Consultations to the urology service during a 3-week period (March 16 to April 2, 2020) were triaged and managed via one of 3 pathways: Standard, Telemedicine, or High-Risk. Standard consults were in-person consults with non COVID-19 patients, High-Risk consults were in-person consults with COVID-19 positive/suspected patients, and Telemedicine consults were telephonic consults for low-acuity urologic issues in either group of patients. Patient demographics, consultation parameters and consultation outcomes were compared to consultations from the month of March 2019. Categorical variables were compared using Chi-square test and continuous variables using Mann-Whitney U test. A P value <.05 was considered significant., Results: Between March 16 and April 2, 2020, 53 inpatient consultations were performed. By following our triage pathway, a total of 19/53 consultations (35.8%) were performed via Telemedicine with no in-person exposure, 10/53 consultations (18.9%) were High-Risk, in which we strictly controlled the urology team member in-person contact, and the remainder, 24/53 consultations (45.2%), were performed as Standard in-person encounters. COVID-19 associated consultations represented 18/53 (34.0%) of all consultations during this period, and of these, 8/18 (44.4%) were managed successfully via Telemedicine alone. No team member developed COVID-19 infection., Conclusion: During the COVID-19 pandemic, most urology consultations can be managed in a patient and physician safety-conscious manner, by implementing a novel triage pathway., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To compare the utility of the systematic 12-core prostate biopsy (SB) combined with magnetic resonance imaging (MRI)-targeted lesion biopsy (MRI-TB) vs MRI-TB alone in the diagnosis of high PI-RADS lesions., Materials and Methods: Patients undergoing MRI-TB + SB for suspicious MRI lesions were retrospectively reviewed. These patients had a previous prostate biopsy and were evaluated with MRI to assess the need for a repeat biopsy. Pathologic findings of MRI-TB combined with a SB were compared to those of the patients' previous SB. An upgrade was defined as an increase in the Gleason Score of any prior biopsy. A no-upgrade (NU) MRI-TB was defined as a MRI-TB that did not lead to disease upgrading when compared to SB., Results: A total of 148 patients were analyzed in this study. Of the 255 total lesions (247 lesions with PI-RADS ≥3), 141 were upgraded from the previous biopsy (55.3%). Of these, 104 were upgraded by the MRI-TB (40.8%), and 87 lesions were upgraded by the SB (34.1%). The MRI-TB had a NU rate of 26.2% for all lesions. On subanalysis, the NU rates of PI-RADS 3, 4, and 5 MRI-TBs were 39.3%, 21.2%, and 3.4%, respectively., Conclusion: The NU rate for the MRI-TB in a PIRADS-5 lesion is meager. Men with a PI-RADS 5 lesion may be safely managed with the MRI-TB alone without combining with SB. Men with PI-RADS 3 and 4 lesions should benefit from SB in addition to MRI-TB for accurate management of their disease., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Use of robot-assisted radical prostatectomy (RARP) for prostate cancer is increasing. Structured surgical training and objective assessment are critical for outcomes., Objective: To develop and validate a modular training and assessment pathway via Healthcare Failure Mode and Effect Analysis (HFMEA) for trainees undertaking RARP and evaluate learning curves (LCs) for procedural steps., Design, Setting, and Participants: This multi-institutional (Europe, Australia, and United States) observational prospective study used HFMEA to identify the high-risk steps of RARP. A specialist focus group enabled validation. Fifteen trainees who underwent European Association of Urology robotic surgery curriculum training performed RARP and were assessed by mentors using the tool developed. Results produced LCs for each step. A plateau above score 4 indicated competence., Outcome Measurements and Statistical Analysis: We used a modular training and assessment tool (RARP Assessment Score) to evaluate technical skills. LCs were constructed. Multivariable Kruskal-Wallis, Mann-Whitney U, and κ coefficient analyses were used., Results and Limitations: Five surgeons were observed for 42 console hours to map steps of RARP. HFMEA identified 84 failure modes and 46 potential causes with a hazard score ≥8. Content validation created the RARP Assessment Score: 17 stages and 41 steps. The RARP Assessment Score was acceptable (56.67%), feasible (96.67%), and had educational impact (100%). Fifteen robotic surgery trainees were assessed for 8 mo. In 426 RARP cases (range: 4-79), all procedural steps were attempted by trainees. Trainees were assessed with the RARP Assessment Score by their expert mentors, and LCs for individual steps were plotted. LCs demonstrated plateaus for anterior bladder neck transection (16 cases), posterior bladder neck transection (18 cases), posterior dissection (9 cases), dissection of prostatic pedicle and seminal vesicles (15 cases), and anastomosis (17 cases). Other steps did not plateau during data collection., Conclusions: The RARP Assessment Score based on HFMEA methodology identified critical steps for focused RARP training and assessed surgeons. LCs demonstrate the experience necessary to reach a level of competence in technical skills to protect patients., Patient Summary: We developed a safety and assessment tool to gauge the technical skills of surgeons performing robot-assisted radical prostatectomy. Improvement was monitored, and measures of progress can be used in future to guide mentors when training surgeons to operate safely., (Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a secretory protein that controls cholesterol homeostasis by enhancing endosomal and lysosomal degradation of the low-density lipoprotein receptor (LDL-R). Mutations that cause increased activity of PCSK9 are associated with hypercholesterolemia, atherosclerosis and early cardiovascular disease (CVD), whereas individuals with loss-of-function mutations in PCSK9 are apparently healthy but are hypocholesterolemic and have a dramatically decreased risk of CVD. In this study, we generated virus-like particle (VLP)-based vaccines targeting PCSK9. Mice and macaques vaccinated with bacteriophage VLPs displaying PCSK9-derived peptides developed high titer IgG antibodies that bound to circulating PCSK9. Vaccination was associated with significant reductions in total cholesterol, free cholesterol, phospholipids, and triglycerides. A vaccine targeting PCSK9 may, therefore, be an attractive alternative to monoclonal antibody-based therapies., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

An ideal prophylactic human papillomavirus (HPV) vaccine would provide broadly protective and long-lasting immune responses against all high-risk HPV types, would be effective after a single dose, and would be formulated in such a manner to allow for long-term storage without the necessity for refrigeration. We have developed candidate HPV vaccines consisting of bacteriophage virus-like particles (VLPs) that display a broadly neutralizing epitope derived from the HPV16 minor capsid protein, L2. Immunization with 16L2 VLPs elicited high titer and broadly cross-reactive and cross-neutralizing antibodies against diverse HPV types. In this study we introduce two refinements for our candidate vaccines, with an eye towards enhancing efficacy and clinical applicability in the developing world. First, we assessed the role of antigen dose and boosting on immunogenicity. Mice immunized with 16L2-MS2 VLPs at doses ranging from 2 to 25 μg with or without alum were highly immunogenic at all doses; alum appeared to have an adjuvant effect at the lowest dose. Although boosting enhanced antibody titers, even a single immunization could elicit strong and long-lasting antibody responses. We also developed a method to enhance vaccine stability. Using a spray dry apparatus and a combination of sugars & an amino acid as protein stabilizers, we generated dry powder vaccine formulations of our L2 VLPs. Spray drying of our L2 VLPs did not affect the integrity or immunogenicity of VLPs upon reconstitution. Spray dried VLPs were stable at room temperature and at 37 °C for over one month and the VLPs were highly immunogenic. Taken together, these enhancements are designed to facilitate implementation of a next-generation VLP-based HPV vaccine which addresses U.S. and global disparities in vaccine affordability and access in rural/remote populations., (Published by Elsevier Ltd.)

Background: Chronic obstructive pulmonary disease (COPD) is frequently misdiagnosed or undiagnosed, which can delay disease management interventions., Purpose: The Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH1) study assessed whether screening using the COPD Population Screener (COPD-PS) questionnaire to detect COPD risk factors and symptoms, with or without a handheld spirometer (copd-6) to detect airflow limitation, can increase yields of COPD diagnosis and respiratory-related clinician actions in primary care., Design: A prospective, multi-center, pragmatic, comparative-effectiveness, cluster-randomized study conducted from September 2010 to October 2011 (data analyzed from December 2011 to January 2013)., Participants: Men and women aged ≥40 years visiting their participating primary care practice for any reason., Intervention: Practices were randomized to three study arms: COPD-PS + copd-6, COPD-PS alone, and usual care (no interventions). No practices received any specific education about COPD or its diagnosis., Main Outcome Measures: The primary endpoint was yield of new clinical COPD diagnosis; the secondary endpoint was yield of respiratory-related clinician actions., Results: Of 9,704 patients enrolled, 8,770 had no prior COPD diagnosis and were included in endpoint analyses. Both interventions significantly increased COPD diagnostic yield over 8 weeks. Compared with a mean yield of 0.49% (0.13%) (controls), yields were 1.07% (0.20%) (OR=2.20, 95% CI=1.26, 3.84, p=0.006) and 1.16% (0.22%) (OR=2.38, 95% CI=1.38, 4.13, p=0.002) for COPD-PS and COPD-PS+copd-6 study arms, respectively. Respiratory-related clinician actions were not significantly different across study arms., Conclusions: Office-based assessment can significantly increase COPD diagnosis by primary care physicians. Future trials must evaluate whether screening can improve outcomes for patients with COPD., (Copyright © 2014 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Antibodies targeting epitopes within the amino terminus of the minor capsid protein L2 of human papillomavirus (HPV) are broadly neutralizing against diverse HPV isolates. We have constructed bacteriophage virus-like particle (VLP)-based vaccines that display short L2 peptides and elicit high-titer and broadly protective antibody responses. Here, we further characterize two additional features of these VLP-based vaccines; the longevity of protection and the role of endogenous and exogenous adjuvants on the magnitude and characteristics of the antibody response. We show that vaccinated mice have long-lived antibody responses against L2, persisting over 18 months after vaccination. Vaccinated mice were strongly protected against infection by diverse HPV pseudoviruses over a year after immunization. We also show that exogenous and endogenous adjuvants (LPS and encapsidated single-stranded RNA) have minor effects on antibody titers. Immunization with VLPs containing encapsidated ssRNA predominantly shifts the response to a Th1, rather than a Th2-like response. Importantly, immunization with L2-VLPs (without endogenous and exogenous adjuvants) in the presence of alum hydroxide elicited a robust antibody response., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objectives: To review the incidence and management of rectal injury in 4400 consecutive cases of robotic radical prostatectomy at a single institution., Material and Methods: From September 2001 to September 2009, 4400 patients underwent robotic radical prostatectomy. We reviewed the intraoperative and postoperative data from patients with rectal injuries. Once recognized, the rectal injuries were closed in 2 layers. Clear liquids were started the day after surgery. Healing of the vesicourethral anastomosis was confirmed by cystography 5-14 days postoperatively., Results: Rectal injuries were identified in 10 patients (0.2%). The mean patient age was 58.6 years (range 44-68), and the mean body mass index was 25.8 kg/m(2) (range 22-29). The mean prostate-specific antigen level was 7.1 ng/mL (range 0.9-14.8), and the mean prostate weight was 58.9 g (range 22-102). The clinical stage was T1c, T2a, and T2c in 7, 2, and 1 patient, respectively. The preoperative Gleason score was 6, 7, and 8 in 3, 3, and 4 patients, respectively. All rectal injuries were diagnosed and repaired intraoperatively. Of the 10 patients, 9 had an uneventful postoperative course. The average urethral catheterization time for these patients was 14 days (range 6-21). One patient had gross fecal spillage and developed a rectourethral fistula requiring a delayed diverting colostomy. No perioperative mortality occurred., Conclusions: We found a low incidence of rectal injury during robotic radical prostatectomy. We have also demonstrated that rectal injuries can be managed primarily with meticulous closure with minimal morbidity., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the effect of previous robot-assisted radical prostatectomy (RARP) case volume on the outcomes of robot-assisted radical cystectomy. Little is known regarding the effect of previous robotic surgical experience on the implementation and execution of robot-assisted radical cystectomy., Methods: Using the International Robotic Cystectomy Consortium database, 496 patients were identified who had undergone robot-assisted radical cystectomy by 21 surgeons at 14 institutions from 2003 to 2009. The surgeons were divided into 4 groups according to their previous RARP experience (≤ 50, 51-100, 101-150, and > 150 cases). The overall operative time, blood loss, lymph node yield, pathologic stage, and surgical margin status were compared among the 4 groups using chi-square analysis., Results: The mean operative time was 386 minutes (range 178-827). The mean estimated blood loss was 408 mL (range 25-3500). The operative time and blood loss were both significantly associated with previous RARP experience (P < .001). The mean lymph node count was 17.8 nodes (range 0-68). Lymph node yield and increased pathologic stage were significantly associated with previous RARP experience (P < .001). Finally, 34 (7.0%) of the 482 patients had a positive surgical margin. Margin status was not significantly associated with previous RARP experience (P = .089)., Conclusions: Previous RARP case volume might affect the operative time, blood loss, and lymph node yield at robot-assisted radical cystectomy. In addition, surgeons with increased RARP experience operated on patients with more advanced tumors. Previous RARP experience, however, did not appear to affect the surgical margin status., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Background: Robot-assisted radical cystectomy (RARC) has evolved as a minimally invasive alternative to open radical cystectomy for patients with invasive bladder cancer., Objective: We sought to define the learning curve for RARC by evaluating results from a multicenter, contemporary, consecutive series of patients who underwent this procedure., Design, Setting, and Participants: Utilizing the International Robotic Cystectomy Consortium database, a prospectively maintained and institutional review board-approved database, we identified 496 patients who underwent RARC by 21 surgeons at 14 institutions from 2003 to 2009., Measurements: Cut-off points for operative time, lymph node yield (LNY), estimated blood loss (EBL), and margin positivity were identified. Using specifically designed statistical mixed models, we were able to inversely predict the number of patients required for an institution to reach the predetermined cut-off points., Results and Limitations: Mean operative time was 386 min, mean EBL was 408 ml, and mean LNY was 18. Overall, 34 of 482 patients (7%) had a positive surgical margin (PSM). Using statistical models, it was estimated that 21 patients were required for operative time to reach 6.5h and 8, 20, and 30 patients were required to reach an LNY of 12, 16, and 20, respectively. For all patients, PSM rates of <5% were achieved after 30 patients. For patients with pathologic stage higher than T2, PSM rates of <15% were achieved after 24 patients., Conclusions: RARC is a challenging procedure but is a technique that is reproducible throughout multiple centers. This report helps to define the learning curve for RARC and demonstrates an acceptable level of proficiency by the 30th case for proxy measures of RARC quality., (Copyright (c) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: Laparoscopic partial nephrectomy is gaining acceptance as an alternative to open surgery for small renal tumours, although technical difficulty of intracorporeal suturing and concerns over warm ischemia time are limitations. Previous work has demonstrated that suturing with the robotic system is easier compared with laparoscopy. We believe the robot has an application and we report our initial experience in 10 patients undergoing robotic partial nephrectomy., Methods: Ten patients with small exophytic renal masses underwent intraperitoneal robotic partial nephrectomy. Principles of traditional open surgery were followed and intraoperative ultrasound was used to define resection margins. The renal artery was clamped with laparoscopic bulldog clamps and indigo carmine was administered intravenously to detect entry into collecting system. Suture closure and FLOSEAL were used for hemostasis. Frozen sections were obtained in all patients., Results: Seven men and three women, mean age 59 yr, underwent robotic partial nephrectomy. Mean tumour size was 2 cm. Mean console and warm ischemia time were 158 min and 21 min, respectively. The median hospital stay was 1.5 d. Pathology revealed renal cell carcinoma in eight, oncocytoma in one, and lipoma in one. All resection margins were negative. Follow-up ranged from 6 to 28 mo., Conclusions: Robotic partial nephrectomy is a viable alternative to open or laparoscopic partial nephrectomy in carefully selected patients with small renal tumours. The advantages of the robotic system must be weighed against its cost. Further studies will determine if reduction in procedure complexity warrants the expense of such technology.

Objectives: Robotic radical prostatectomy is a new procedure for treating prostate cancer. Many centers are attempting this new modality but a detailed description of the technique has not yet been published. We report the technique as performed at the Vattikuti Urology Institute., Methods: At Vattikuti Urology Institute, we have performed more than 30 such operations and have standardized the technique for safe and reproducible treatment of prostate cancer. We collected the patient data and surgical logs to improve and standardize this procedure. We recorded the operation and made relevant modifications after reviewing the recordings to improve the outcome., Results: The operation was developed on the scientific foundations of anatomic radical prostatectomy as described by Walsh and the laparoscopic prostatectomy developed at Montsouris. Our technique differs from these procedures because of the need for two surgical teams and the use of fine, endo-wrist instruments with three-dimensional stereoscopic visualization. We describe the patient setup, positioning, port placement, preparation of the robot, docking of the arms, and the surgical steps of performing anatomic prostatectomy with robotic assistance., Conclusions: This report describes the current technique of robotic prostatectomy as developed at the Vattikuti Urology Institute.

Objectives: Neoadjuvant hormonal therapy reduces positive margins in patients undergoing radical prostatectomy. All patients experience a decrease in serum prostate specific antigen (PSA), but not always to a level that is nondetectable. The results of several prospective, randomized trials indicate that the incidence of positive margins decreases with the use of androgen deprivation prior to radical prostatectomy. It has been suggested that a greater decline in PSA levels would result in fewer positive margins. In a recent US trial of patients with T2bNxMO prostate cancer, we reported that 18% of patients randomized to receive 3 months of leuprolide acetate and flutamide had positive margins, compared to 48% of those who had radical prostatectomy alone (P < 0.001). We correlated the PSA levels prior to and following androgen deprivation and the presence of a positive margin following radical prostatectomy (RP)., Methods: One hundred and thirty-seven of 149 patients randomized to receive presurgery androgen deprivation (AD) underwent radical prostatectomy. Of these, 135 had a PSA level obtained both prior to androgen deprivation and prior to surgery. We analyzed the percent positive margins in patients whose PSA values became undetectable and in those whose values remained above 0.1 ng/mL despite androgen deprivation., Results: Eight of 43 patients (19%) with a nadir PSA < or = 0.1 ng/mL had a positive surgical margin and 16/92 (17%) with a nadir PSA > 0.1 ng/mL had tumor at the margin. There were no statistical differences in these two groups (P = 1.0 by Fisher's Exact Test [two-tailed], and the Pearson correlation was -0.015)., Conclusions: There was no correlation between an undetectable PSA and a PSA > 0.1 ng/mL and the presence of tumor at the margin when 3 months of AD was given prior to RP. It is possible that longer periods of AD prior to RP will reduce PSA to an undetectable level in a higher percent of patients. However, these data suggest that an undetectable level will not result in less positive margins.

Objectives: Bropirimine is an orally administered immunostimulant that has been shown to have activity against carcinoma in situ (CIS) of the bladder. To further assess this potential activity, bropirimine was administered to 42 patients for bladder CIS in a Phase II trial., Methods: Patients were treated with bropirimine 3.0 g/day by mouth for 3 consecutive days each week up to 1 year. Cystoscopy with biopsies and bladder wash cytology were performed quarterly., Results: Twenty (61%) of 33 evaluable patients converted malignant biopsies and bladder wash cytology to negative, including 6 (50%) of 12 who failed prior bacillus Calmette-Guérin (BCG) immunotherapy, 14 (67%) of 21 who had not received prior BCG therapy, and 12 (80%) of 15 with primary CIS. Median response duration exceeds 21 months. Four of the 20 responders did have a papillary tumor recurrence at 3 to 15 months, all Stage Ta or T1. Mild toxicity (grade I or II) suggestive to interferon induction or administration occurred in one third of patients. Headache, transient hepatic enzyme elevations, skin rash, and arthralgias each occurred in 5% to 14% of the patients, with nausea or emesis in 21%. Grade 1 tachycardia/palpitations or chest pain each were noted in 5%., Conclusions: Oral bropirimine can induce remission of bladder CIS with acceptable toxicity at 3.0 g/day. Bropirimine may be a valuable alternative to cystectomy for some failures of BCG therapy and may have the potential to replace BCG as front-line therapy because of its ease of administration.