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The optimal prognostic value of testosterone following androgen deprivation therapy (ADT) is controversial. We studied the effect of serum testosterone levels on clinical outcome in localized prostate cancer (PCa) treated with ADT and high-dose radiotherapy (HRT).The DART01/05 trial randomized 355 men with intermediate and high-risk PCa to 4 months of ADT plus HRT (STADT, N = 178) or the same treatment followed by 24 months of ADT (LTADT, N = 177). This study included patients treated with LTADT who had at least 3 determinations of testosterone during ADT (N = 154). Patients were stratified into 3 subgroups by testosterone level: minimum20 ng/dL; median 20-49 ng/dL; and maximum ≥50 ng/dL. Kaplan-Meyer and Cox regression analysis were used for overall survival (OS) and FineGray regression model for metastasis free survival (MFS), biochemical disease-free survival (bDFS) and time to TT recovery.There were no statistically significant differences in 10-year bDFS, MFS, or OS between the20 ng/mL and 20-49 ng/dL subgroups. Multivariate analysis showed that a median testosterone ≥50 ng/dL was significantly associated with a decrease in bDFS (HR: 6.58, 95%CI 1.28-33.76, p = 0.03). Time to testosterone recovery after ADT did not correlate with bDFS, MFS, or OS and was not significantly associated with any of the testosterone subgroups.Our results do not support the concept that additional serum testosterone suppression below 20 ng/dL is associated with better outcomes than 20-49 ng/dL. Time to testosterone recovery after ADT and HRT did not impact clinical failure.

To develop a model that predicts survival in patients irradiated for metastatic spinal cord compression (MSCC), hence assisting in the decision between a short and a long-course radiotherapy (RT) regimen. 138 patients diagnosed with MSCC and treated with RT alone were included. Based on a multivariate analysis, a scoring system was developed. It included four prognostic variables: age, number of vertebrae, ECOG and histology. Total scores ranged between 14 and 24 points and patients were divided into two groups. The 6-month survival rate was 22% for patients with a score of 14–18 points; and 69% for patients with a score of 19–24 points (P < 0.001). The system exhibits a high specificity and positive predictive value and an appropriate discriminative ability. Patients with scores between 19 and 24 points were found to survive longer, thus a long-course RT appears to be more appropriate.

To evaluate the diagnostic performance of 18F-choline PETCT in staging prostate cancer (PC) and whether the use of this imaging modality changes the therapeutic decision in patients previously staged by conventional imaging. The secondary aim was to determine the prognostic factors associated with positive choline PETCT findings in both detection of disseminated disease and in changes in the therapeutic indication. Multicentre, retrospective, observational study of 269 patients diagnosed with PC. Mean age was 69 ± 9.2 years. Of the 269 patients, 62 (23%) had high-risk localized PC (group 1), 118 (43.9%) biochemical failure after radical prostatectomy (group 2), and 89 (33.1%) biochemical failure after radiotherapy (group 3). None of the patients showed clear evidence of distant disease on computed tomography or bone scans. The following potential prognostic factors were assessed: PSA level at diagnosis; primary and secondary Gleason; Gleason score (GS); clinical and pathologic T and N stage; number of positive cylinders in the biopsy; presence of vascular or lymphatic invasion; status of surgical margins; androgen deprivation therapy (ADT); time to biochemical recurrence; and PSA, PSA doubling time (PSADT), and PSA velocity (PSAV) at failure. Univariate and multivariate analyses were performed, and receiver-operating curves calculated. The mean PSA by groups was, group 1: 31.22 ng/ml, group 2: 2.52 ng/ml and group 3: 5.85 ng/ml. The tumor detection rate with 18F-choline PETCT was 74% (group 1: 85.5%, group 2: 55.1% and group 3: 91%). Prognostic factors for positive 18F-choline PETCT were identified only in group 2: PSA at failure and PSADT. 18F-choline PETCT changed the therapeutic indication in 62.8% (group 1: 71%, group 2: 55.2% and group 3: 70.1%). The prognostic factors for a change in treatment were identified only in group 1: secondary Gleason ≤ 4 and GS ≤ 7 and in group 2: PSA at failure, PSA nadir after surgery and pathologic stage N0. 18F-choline PETCT identified lymph node and/or metastatic disease in 32.7% (group 1: 25.8%, group 2: 29.7% and group 3: 41.6%). Prognostic factors for detecting lymph node/metastasis were identified in the group 2: PSA failure ≥ 1.37 ng/ml and PSADT

Purpose/Objective(s) The optimal duration of androgen deprivation (AD) combined with high-dose radiotherapy (HDRT) in prostate cancer remains a matter of controversy. We did a phase 3 trial designed to determine whether long-term AD (LTAD) is superior to short-term AD (STAD) when combined with HDRT. In this report, we present the 10-year survival results. The hypothesis is that long-term AD (LTAD) compared to short-term AD (STAD) improves overall survival among high-risk patients receiving HDRT. Materials/Methods This open-label, phase 3 randomized controlled trial, recruited patients from ten university hospitals throughout Spain. Eligibility included patients with cT1c-T3aN0M0 adenocarcinoma of prostate with intermediate and high-risk factors according to NCCN criteria and PSA less than 100 ng/ml. All patients received 4 months of neoadjuvant and concomitant AD (STAD) + HDRT (median radiation dose 78 Gy) before randomization to adjuvant goserelin for two years (LTAD). Stratification was performed according to risk group (intermediate risk [IR] versus high risk [HR]). Study endpoints included overall survival (OS), metastasis free survival (MFS), disease free survival (DFS) and biochemical-disease free survival (bDFS). Survival analyses were done with Kaplan-Meier (KM) curves. Fine & Gray (FG FG FG F&G P = 0.057, HR, 1.12, 95% CI, 0.46 to 2.73). Only 11 patients died from PCa, all of them in the high-risk subgroup. Conclusion Long term results failed to show a significant benefit with LTAD compared to STAD in patients treated with HDRT. The subgroup of patients with high-risk PCa treated with LTAD had a non-significant improvement in bDFS, MFS and OS compared with STAD. The relatively small simple size, a low number of events and an effective salvage treatment could be responsible for the lack of a statistical significance. The trial is registered at ClinicalTrials.gov, number NCT 02175212.

INTRODUCTION: The clinical course in patients with prostate cancer (PCa) after biochemical failure (BF) has received limited attention. This study analyzes survival time from recurrence, patterns of progression, and the efficacy of salvage therapies in patients treated with radical or postoperative radiotherapy (RT). METHODS: This is a multicenter retrospective comparative study of 1135 patients diagnosed with BF and treated with either radical (882) or postoperative (253) RT. Data correspond to the RECAP database. Clinical, tumor, and therapeutic characteristics were collected. Descriptive statistics, survival estimates, and comparisons of survival rates were calculated. RESULTS: Time to BF from initial treatment (RT or surgery) was higher in irradiated patients (51 vs 37months). At a median follow-up of 102months (14-254), the 8-year cause-specific survival (CSS) was 80.5%, without significant differences between the radical (80.1%) and postoperative (83.4%) RT groups. The 8-year metastasis-free survival rate was 57%. 173 patients (15%) died of PCa and 29 (2.5%) of a second cancer. No salvage therapy was given in 15% of pts. Only 5.5% of pts who underwent radical RT had local salvage treatment and 71% received androgen deprivation (AD)±chemotherapy. The worst outcomes were in patients who developed metastases after BF (302pts; 26.5%) and in cases with a Gleason>7. CONCLUSIONS: In PCa treated with radiotherapy, median survival after BF is relatively long. In this sample, no differences in survival rates at 8-years have been found, regardless of the time of radiotherapy administered. AD was the most common treatment after BF. Metastases and high Gleason score are adverse variables. To our knowledge, this is the first study to compare outcomes after BF among patients treated with primary RT vs. those treated with postoperative RT and to evaluate recurrence patterns, treatments administered, and causes of death. The results allow avoiding overtreatment, improving quality of life, without negatively affecting survival.

Nomograms were established to predict biochemical recurrence (BCR) after radiotherapy (RT) with a low weight of the characteristic variables of RT and androgen deprivation therapy (ADT). Our aim is to provide a new stratified tool for predicting BCR at 4 and 7 years in patients treated using RT with radical intent. A retrospective, nonrandomized analysis was performed on 5044 prostate cancer (PCa) patients with median age 70 years, who received RT—with or without ADT—between November 1992 and May 2007. Median follow-up was 5.5 years. BCR was defined as a rise in serum prostate-specific antigen (PSA) of 2 ng/ml over the post-treatment PSA nadir. Univariate association between predictor variables and BCR was assessed by the log-rank test, and three linked nomograms were created for multivariate prognosis of BCR-free survival. Each nomogram corresponds to a category of the Gleason score—either 6,7, or 8–10—and all of them were created from a single proportional hazards regression model stratified also by months of ADT (0, 1–6, 7–12, 13–24, 25–36, 36–60). The performance of this model was analyzed by calibration, discrimination, and clinical utility. Initial PSA, clinical stage, and RT dose were significant variables (p

The purpose of the study was to describe infrastructures, treatment modalities, and workload in radiation oncology (RO) in Spain, referred particularly to prostate cancer (PC). An epidemiologic, cross-sectional study was performed during 2008-2009. A study-specific questionnaire was sent to the 108 RO-registered departments. One hundred and two departments answered the survey, and six were contacted by telephone. Centers operated 236 treatment units: 23 (9.7 %) cobalt machines, 37 (15.7 %) mono-energetic linear accelerators, and 176 (74.6 %) multi-energy linear accelerators. Sixty-one (56.4 %) and 33 (30.5 %) departments, respectively, reported intensity-modulated radiation therapy (IMRT) and image-guided RT (IGRT) capabilities; three-dimensional-conformal RT was used in 75.8 % of patients. Virtual simulators were present in 95 departments (88.0 %), 35 use conventional simulators. Fifty-one departments (47.2 %) have brachytherapy units, 38 (35.2 %) perform prostatic implants. Departments saw a mean of 24.9 new patients/week; the number of patients treated annually was 102,054, corresponding to 88.4 % of patients with a RT indication. In 56.5 % of the hospitals, multidisciplinary teams were available to treat PC. Results provide an accurate picture of current situation of RO in Spain, showing a trend toward the progressive introduction of new technologies (IMRT, IGRT, brachytherapy).

rectal dose and serving as a fiducial marker in patients undergoing radiation therapy for prostate cancer. Materials/Methods: Biodegradable balloon was inserted transperineally, between the anterior rectum and the prostate, through guidance of transrectal ultrasound. Following insertion, the balloon was inflated with sterile physiological solution and sealed. The procedure was performed under mild sedation and in an outpatient clinic. A week later the patients underwent CT simulation and three weeks later they started the radiation course. The radiation protocol consisted of 2.5 Gy once a day, 5 times a week for 28 fractions, to a total dose of 70 Gy in 5 pts. The treatment was delivered through volumetric modulated arc therapy and accuracy was evaluated through cone beam CT (CBCT). Results: Six patients, so far, underwent implantation. Their characteristics include mean age 71 years (range, 61-79 years), PSA 9.3 (range, 5.9-17.3), Gleason score 3+3 in 5 pts and 4+3 in one, and stage T1c (5 pts) and T2 (1 pt). The dimension of the balloon were 4 x 2 x 1.5 cm (CC, lateral and AP). One patient developed urinary retention (the urine catheter was removed a day later) and another had mild bleeding (spontaneously stopped, stable parameters). Following treatment planning the mean V70 of the rectum was 0 (range, 0-0.3) V60 7.1 (range, 2-16) and the V50 was 23 (range, 9-39). The V60 of the bladder was 21 (range, 6-41). The balloon was demonstrated in the CBCT reconstruction and served as a reference point for daily radiation delivery. No immediate side effects were noted during the treatment course. Along a mean F/U of 8 months (range, 6-10 months) 1 out of 6 pts developed grade 1 rectal toxicity and urinary toxicity. No other complications were noted. Conclusions: The biodegradable perineal balloon has a good safety profile, and is efficient in reducing the dose to the rectal wall and in serving as a fiducial marker. Higher daily radiation dose and possible injection of contrast material into the balloon are currently being considered. Author Disclosure: R. Ben-Yosef: L. Stock Options; yes. T. Heres: None. A. Berniger: None. R. Carmi: None. I. lvovich: None. Y. Genesin: None.