The aim of this paper was to compare the perioperative and postoperative results of photoselective vaporization of the prostate with the GreenLight-XPS 180 Watt System (PVP) and transurethral resection of the prostate (TURP). This retrospective study included 140 men who underwent PVP and 114 men who underwent TURP for symptomatic benign prostate enlargement (BPE) between June 2010 and February 2015. The primary outcome measures were the patient reported outcome, operative results, International Prostate Symptom Score-Quality of Life (IPSS-QoL), complication rates, catheterization time, and length of hospital stay. The median follow-up times were 27 months (range 14–44) for the PVP group and 36 months (range 25–47) for the TURP group. The patient characteristics were well balanced in both groups with a median age of 71 years (PVP group) vs. 70 years (TURP group) and a comparable prostate volume (median 50 mL in the PVP group vs. 45 mL in the TURP group). The IPSS-QoL was significantly higher in the PVP group than in the TURP group (median 22 + 4; range 16–27 + 3−5 vs. median 19 + 3; range 15−23 + 3−4; p = 0.02). Men undergoing PVP were more likely to be on anticoagulants (PVP group n = 23; 16% vs. TURP group n = 2; 2%, p < 0.001). The median operation time (OT; min) for both procedures was comparable with 68 min (PVP group; range 53–91) vs. 67 min (TURP group; range 46–85). The rate of severe intraoperative bleeding was significantly lower in the PVP group than in the TURP group (n = 7; 5% vs. n = 16; 14%; p = 0.01). The postoperative catheterization time and length of hospital stay was significantly lower in the PVP group (median 1–2 days; range 1–4) vs. the TURP group (median 2–4 days; range 2–5; both p < 0.001). Complication rates (Clavien-Dindo classification ≥III) based on the follow-up data showed no statistically significant difference between the PVP group and the TURP group (n = 6; 4% vs. n = 6; 5%; p = 0.28). The IPSS on follow-up showed an equivalent reduction in symptoms for both treatment modalities (IPSS-QoL of 5 + 1; range 2–11 + 0−2 for both). There were no differences concerning urge (PVP group n = 3; 2% vs. TURP group n = 3; 3%; p = 0.90) and men were similarly satisfied with the postoperative outcome (PVP group 92% vs. TURP group 87%; p = 0.43). The PVP group was associated with a shorter hospitalization time and showed a reduced risk of bleeding, despite patients remaining on anticoagulants, without increasing the overall operative time. There was no difference in the patient reported outcome for both procedures.

Objective To investigate non‐inferiority of intermittent docetaxel compared to continuous docetaxel in patients with metastatic castration‐resistant prostate cancer ( mCRPC ). Patient and Methods The investigator initiated randomised phase III study included 187 chemotherapy‐naïve patients with mCRPC who were allocated to two treatment arms: intermittent docetaxel and continuous docetaxel. Docetaxel was applied in both arms as weekly (35 mg/m 2 ) or 3‐weekly (75 mg/m 2 ). The primary endpoint was 1‐year survival, which was tested for non‐inferiority (margin δ = 0.125). The secondary endpoints were: overall survival ( OS ), progression‐free survival ( PFS ), median time to treatment failure ( TTF ), and toxicity. Results Of 156 eligible patients, 78 were allocated to each arm. The intermittent treatment met the non‐inferiority criteria for 1‐year survival (two‐sided 95% confidence interval, −0.12, 18, P = 0.022), but not for OS , according to the result of a post hoc analysis. The differences between the study arms in PFS and TTF were not significant. The median (range) treatment holiday in the intermittent arm was 110 (13–486) days, or 38% of the overall treatment duration. Safety profiles of both study arms were comparable. The main limitation of this study was that the planned number of patients could not be recruited. Conclusion Intermittent docetaxel chemotherapy was non‐inferior to continuous therapy for 1‐year survival; non‐inferiority in regard to OS was not reached.

Purpose: The study aimed to evaluate progression of GreenLight-XPS 180 W photoselective vaporization of the prostate (GL-XPS) with respect to effectiveness, efficacy, and safety over time at a tertiary referral high volume center. Methods: The retrospective study included 375 men who underwent GL-XPS for symptomatic benign prostate obstruction (BPO) between June 2010 and February 2015. Primary outcome measurements were operation time (OT; min) and effective laser time (LT; min of OT) analyzed with regard to prostatic volume (PV; mL) (group 1 <40 mL up to 4 >80 mL in 20 mL steps) and the year of surgery (2010–2015). Results: The median age was 72 years (range 64–79), the median PV was 58 mL (range 33–98) and the median PV increased from 42 mL in 2012 to 80 mL in 2015. The OT and LT clearly correlated with the PV, being doubled for glands of median 95 mL compared to median 30 mL while the applied laser energy per LT likewise steadily increased. Overall, both OT and LT could be significantly reduced each year by 37% (OT; p < 0.05) and 36% (LT; p < 0.05) within 5 years. The hospital stay (days) and catheterization time (days) remained constant, without any changes over time. The overall complication rate (Clavien-Dindo >2) ranged from 36 to 15% between 2010 and 2015. The pre (median 22 + 4) and postoperative International Prostate Symptom Score-Quality of Life (median 5 + 1) showed a sufficient reduction in symptomatic BPO. Conclusion: GL-XPS is a safe and effective surgical method for symptomatic BPO. Our single center experience showed a significant improvement of both OT and effective LT within 5 years whilst maintaining stable low complication rate and high patient satisfaction.

5005 Background: A randomized phase III study investigating the non-inferiority of an intermittent docetaxel compared to a continuous docetaxel treatment for patients with castration-resistant prostate cancer (CRPC). Methods: 187 patients were randomized to either an intermittent docetaxel treatment or to a continuous docetaxel treatment until discontinuation (docetaxel application in both arms was weekly 35mg/m2 or three-weekly 75mg/m2). The intermittent arm received docetaxel for one study sequence of 12 weeks and then paused until clinical disease progression, defined by one of the following criteria: increased serum PSA > 4ng/ml with an 50% increase over baseline level, radiological or symptomatic progression. The primary endpoint was one-year survival, which was tested for non-inferiority (efficacy margin 12.5 %). Secondary endpoints were overall survival (OS), progression free survival (PFS), median time to treatment failure (TTF) and toxicity. Final recruitment was not reached. Results: Of 156 eligible patients, 78 were allocated to each arm. One-year survival was 72.6% in the continuous arm vs. 75.8% in the intermittent arm and median OS 18.3 months (95% CI: 15-21.5) vs. 19.3 months (95% CI: 4.7-6.1) (P= .535). The intermittent treatment met the non-inferiority criteria in one year survival (difference to lower 95% CI: -0.1201), but not for OS, according to the result of a post-hoc analysis. The differences between the study arms in PFS and TTF were not significant. The median treatment holiday in the intermittent arm was 15 weeks (range 1-69), or 38% of the overall treatment duration. Safety profiles of both study arms were comparable. Conclusions: The intermittent docetaxel chemotherapy was non-inferior to a continuous therapy in one-year survival. It was well tolerated and may present a treatment option for patients with CRPC.

ObjectiveThe ARO 96-02 trial primarily compared wait-and-see (WS, arm A) with adjuvant radiation therapy (ART, arm B) in prostate cancer patients who achieved an undetectable prostate-specific antigen (PSA) after radical prostatectomy (RP). Here, we report the outcome with up to 12 years of follow-up of patients who retained a post-RP detectable PSA and received salvage radiation therapy (SRT, arm C).Methods and MaterialsFor the study, 388 patients with pT3-4pN0 prostate cancer with positive or negative surgical margins were recruited. After RP, 307 men achieved an undetectable PSA (arms A + B). In 78 patients the PSA remained above thresholds (median 0.6, range 0.05-5.6 ng/mL). Of the latter, 74 consented to receive 66 Gy to the prostate bed, and SRT was applied at a median of 86 days after RP. Clinical relapse-free survival, metastasis-free survival, and overall survival were determined by the Kaplan-Meier method.ResultsPatients with persisting PSA after RP had higher preoperative PSA values, higher tumor stages, higher Gleason scores, and more positive surgical margins than did patients in arms A + B. For the 74 patients, the 10-year clinical relapse-free survival rate was 63%. Forty-three men had hormone therapy; 12 experienced distant metastases; 23 patients died. Compared with men who did achieve an undetectable PSA, the arm-C patients fared significantly worse, with a 10-year metastasis-free survival of 67% versus 83% and overall survival of 68% versus 84%, respectively. In Cox regression analysis, Gleason score ≥8 (hazard ratio [HR] 2.8), pT ≥ 3c (HR 2.4), and extraprostatic extension ≥2 mm (HR 3.6) were unfavorable risk factors of progression.ConclusionsA persisting PSA after prostatectomy seems to be an important prognosticator of clinical progression for pT3 tumors. It correlates with a higher rate of distant metastases and with worse overall survival. A larger prospective study is required to determine which patient subgroups will benefit most from which treatment option.

e16064 Background: Docetaxel (DOC) and estramustine phosphate (EMP) have shown to exert a survival benefit in mCRPC. Anemia is one of the significant side effects associated the DOC with negative effect on progression and survival. We evaluated the effect of epoeitin-a on overall survival, quality of life and hematoxicity ≥ grade 3. Methods: 139 pts with mCRPC were randomized to DOC at 35 mg/m2 on days 2, 9, 16 of a 4-week cycle repeated 3 times. EMP was given at 140 mg TID on days 1,2,3, 8,9,10 and 15,16 17. In group A EPO was administered at a dose of 40.000 IE/week at a hemoglobin level < 10.5 g/dl and it was continued until an upper level of 13.0 g/dl; in group B anemia was treated with best supportive care. Primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival, anemia ≥ 3, quality of life and treatment-associated toxicity according to NCI-CTC. Results: 75 and 64 pts were enrolled in group A and B, resp. Median age was 64.3 and 64.9 years in group A and B, resp. Mean follow-up was 30.9 and 47.3 months in group A and B, resp. Mean treatment duration was 25.5 vs 41.3 weeks in group A and B (p = 0.004), mean number of treatment sequences was 1.57 vs 2.19 (p = 0.01); mean total dose of DOC was significantly higher in group A vs B (p = 0.005). We identified significant differences in HB-levels < 10 g/dl at the end of DOC between group A and B (9.1% vs 24.6%, p = 0.024), frequency of red blood cell transfusions (p = 0.026), development of grade 3/4 toxicities (2.1% vs 3.7%, p = 0.009) which comprised leukopenia (p = 0.036) and thrombocytopenia (p = 0.030) to a similar extent. PFS after sequence1 and 2 was significantly different in group A vs B (p = 0.012 and p = 0.06, resp). Median OS was longer in group A with a trend to significance (13.7 vs 10.8 months, p = 0.06), whereas overall survival rate was significantly higher (62.5% vs 29.3%, p < 0.001). Conclusions: Supportive treatment with EPO results in significantly reduced frequencies of TAE, significant improvement of OS and PFS which was a true effect of elevated HB-levels during treatment. Supportive treatment with EPO seems reasonable in pts experiencing significant anemia during DOC-therapy. Clinical trial information: AUO-AP/33/02.

Background: Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy (ART) compared with a wait-and-see (WS) policy.Objective: To determine the efficiency of ART after a 10-yr follow-up in the ARO 96-02 study.Design, setting, and participants: After RP, 388 patients with pT3 pN0 prostate cancer (PCa) were randomized to WS or three-dimensional conformal ART with 60 Gy. The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP (ITT2 population)-that is, 159 WS plus 148 ART men.Outcome measurements and statistical analysis: The primary end point of the study was progression-free survival (PFS) (events: biochemical recurrence, clinical recurrence, or death). Outcomes were compared by log-rank test. Cox regression analysis served to identify variables influencing the course of disease.Results and limitations: The median follow-up was 111 mo for ART and 113 mo for WS. At 10 yr, PFS was 56% for ART and 35% for WS (p < 0.0001). In pT3b and R1 patients, the rates for WS even dropped to 28% and 27%, respectively. Of all 307 ITT2 patients, 15 died from PCa, and 28 died for other or unknown reasons. Neither metastasis-free survival nor overall survival was significantly improved by ART. However, the study was underpowered for these end points. The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity. No grade 4 events occurred.Conclusions: Compared with WS, ART reduced the risk of (biochemical) progression with a hazard ratio of 0.51 in pT3 PCa. With only one grade 3 case of late toxicity, ART was safe.Patient summary: Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors. (C) 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Patients with prostate cancer face the difficult decision between a wide range of therapeutic options. These men require elaborate information about their individual risk profile and the therapeutic strategies´ risks and benefits to choose the best possible option. In order to detect time trends and quality improvements between an early patient population (2003/2004) and a later reference group (2007/2008) data was analysed with regards to epidemiologic parameters, differences in diagnostics and the type and ranking of the recommended therapies taking into account changes to Gleason Grading System and implementation of new therapeutic strategies, particularly Active surveillance, in 2005.

BACKGROUND:Cabazitaxel (Cbz) is an approved second-line treatment in metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy with a significant survival benefit compared with mitoxantrone. However, grade 3/4 toxicities were reported in 82% of patients. OBJECTIVE:To report on the safety results of mCRPC patients treated within a compassionate-use programme in Germany. DESIGN, SETTING, AND PARTICIPANTS:A total of 111 patients with a mean age of 67.9 yr (range: 49-81 yr) and progressive mCRPC were included. Patients had received a mean number of 12.7 ± 10.8 cycles (range: 6-69 cycles) of docetaxel with a mean cumulative dose of 970.9 mg/m(2); mean time from last docetaxel application to progression was 6.95 mo (range: 2-54 mo). Of the patients, 31.5% progressed by prostate-specific antigen (PSA) increase only; the remainder had a combination of PSA increase and clinical progression. INTERVENTION:Cbz at a dosage of 25mg/m(2) intravenously every 3 wk combined with 5mg of oral prednisone twice a day. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:Treatment-associated toxicity was the primary study end point; progression-free and overall survival were secondary end points. A descriptive statistical analysis was performed. RESULTS AND LIMITATIONS:Patients received a mean number of 6.5 ± 2.2 cycles of Cbz and a mean cumulative dose of 160.3 ± 51.5mg/m(2). Grade 3 and 4 treatment-emergent adverse events were recorded in 34 patients (30.6%) and 18 patients (16.2%), respectively. Grade 3/4 anaemia, neutropenia, and thrombocytopenia were reported in 4.5%, 7.2%, and 0.9% of the patients, respectively. Neutropenic fever was reported in 1.8% of the patients. Grade 3/4 gastrointestinal toxicity was identified in 4.5% of the patients. Three patients died because of Cbz-related toxicity. Granulocyte colony-stimulating growth factors were used in 17.1% of patients. The limitations are due to the nonrandomised nature of the trial. CONCLUSIONS:Treatment with Cbz is tolerable and is associated with a low incidence of serious adverse events in a real-world patient population with CRPC. The outcome of serious adverse events can be minimised with proactive treatment management and conscientious monitoring.

Transurethral resection of the prostate (TURP) is a challenging operation for residents with limited endoscopic experience. A number of virtual TURP simulators have been validated in the past. This study is the first description and preliminary evaluation of a non‐virtual, low‐cost TURP trainer as a teaching tool for residents in urology.

BACKGROUND:Kidney allograft function crucially depends on the quality of organ perfusion. Duplex sonography, however, frequently reveals hypoperfused segments that remained undetectable to visual inspection intraoperatively. To date, no imaging system supplementing the surgeon's experience has achieved clinical acceptance. The present work examines whether laser-assisted indocyanine green (ICG) fluorescence-videography can be used as a safe and sensitive technique for the intraoperative assessment of renal allograft perfusion.METHODS:Intraoperative assessment of organ perfusion by laser-assisted ICG fluorescence videography (IC-VIEW) was performed in 10 consecutive de novo renal transplantations. The IC-VIEW system allows the visualization of graft perfusion by the fluorescein dye ICG that emits infrared light after exposure to laser light.RESULTS:Perfusion measurements were successful in all 10 transplant recipients. Fluorescence videography produced brilliant, sharply contrasted images of the organs, allowing the detection of even small perfusion deficits. Remarkably, this technique detected 1 large perfusion defect that had remained imperceptible to visual inspection. Repositioning of the graft led to a homogeneous overall perfusion. There were no complications with the ICG injection or the imaging device.CONCLUSION:Laser-assisted ICG fluorescence videography is a feasible and safe technique for the intraoperative assessment of renal allograft perfusion.

Background: Sorafenib and sunitinib are tyrosine kinase inhibitors with largely overlapping specificities, approved for the treatment of metastatic renal-cell carcinoma (RCC). It was unclear whether the similarities of the two drugs would lead to complete cross-resistance, or whether sequential application would be efficacious. Methods: Patients with metastatic RCC and progression on sorafenib treatment were treated with repeated cycles of sunitinib, 50 mg for 4 weeks, followed by a 2-week break. Response (Response Evaluation Criteria in Solid Tumors, RECIST) was assessed every second cycle. Results: A total of 22 patients with progression on sorafenib were accrued. Initially, sorafenib treatment was efficacious in all patients, with 7 showing partial response (PR) and 15 stable disease (SD), and subsequent disease progression. With 4 PRs (18%) and 12 SD (55%) a disease control rate of 73% was achieved. The median progression-free survival (PFS) on sunitinib was 21.5 weeks; median overall survival (OS) was not reached. Estimated 1-year PFS and OS were 31 and 60%, respectively. There was no apparent relationship between response to sorafenib and outcome on sunitinib. Conclusion: In our cohort of patients with RCC and progression after initial efficacy of sorafenib, the efficacy data of second-line sunitinib were close to published results of first-line treatment, suggesting limited clinically relevant cross-resistance.

PURPOSELocal failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Two randomized trials demonstrated an advantage for adjuvant radiotherapy (RT) compared with a wait-and-see policy. We conducted a randomized, controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen (PSA) level after RP.METHODSAfter RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT. Eligible patients had pT3 pN0 tumors. Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%). Of the remaining 307 patients, 34 patients on the RT arm did not receive RT and five patients on the wait-and-see arm received RT. Therefore, 114 patients underwent RT and 154 patients were treated with a wait-and-see policy. The primary end point was biochemical progression-free survival.RESULTSBiochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group (72%; 95% CI, 65% to 81%; v 54%, 95% CI, 45% to 63%; hazard ratio = 0.53; 95% CI, 0.37 to 0.79; P = .0015). On univariate analysis, Gleason score more than 6 and less than 7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome. The rate of grade 3 to 4 late adverse effects was 0.3%.CONCLUSIONAdjuvant RT for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Further follow-up is needed to assess the effect on metastases-free and overall survival.

You have accessJournal of UrologyWednesday, May 23, 2007, 10:40 am1 Apr 2007LBA1723: Intermittent Versus Continuous Androgen Suppression in Advanced Prostate Cancer - A Randomised Prospective Study Kurt Miller, Ursula Steiner, Anja Lingnau, Ulrich Witzch, Ahmad Haider, Udo Wachter, Christoph Rüssel, and Jens Altwein Kurt MillerKurt Miller More articles by this author , Ursula SteinerUrsula Steiner More articles by this author , Anja LingnauAnja Lingnau More articles by this author , Ulrich WitzchUlrich Witzch More articles by this author , Ahmad HaiderAhmad Haider More articles by this author , Udo WachterUdo Wachter More articles by this author , Christoph RüsselChristoph Rüssel More articles by this author , and Jens AltweinJens Altwein More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(18)32130-XAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "LBA1723: Intermittent Versus Continuous Androgen Suppression in Advanced Prostate Cancer - A Randomised Prospective Study." The Journal of Urology, 177(4S), p. 573 © 2016 by American Urological AssociationFiguresReferencesRelatedDetails Volume 177Issue 4SApril 2007Page: 573 Advertisement Copyright & Permissions© 2016 by American Urological AssociationMetricsAuthor Information Kurt Miller More articles by this author Ursula Steiner More articles by this author Anja Lingnau More articles by this author Ulrich Witzch More articles by this author Ahmad Haider More articles by this author Udo Wachter More articles by this author Christoph Rüssel More articles by this author Jens Altwein More articles by this author Expand All Advertisement PDF downloadLoading ...

BACKGROUND:Radiation therapy is a treatment option for patients with rising PSA after radical prostatectomy without histological evidence of local relapse and no signs of distant metastases. Prior to radiotherapy there is no certainty whether a patient is going to respond to the treatment or not. When total doses of more than 60 Gy are given there is an exponential rise in treatment-related late toxicity. Therefore those patients in whom radiotherapy later appears to be ineffective may benefit from a dose restriction to 50-60 Gy. The aim of this study was to examine the prognostic value of PSA levels evaluated during radiotherapy.PATIENTS AND METHODS:41 patients with rising PSA level following prostatectomy received radiotherapy to the prostatic bed and were treated up to a median dose of 66.6 Gy. We evaluated serum PSA levels during radiotherapy at 30 Gy, 50 Gy, and 60 Gy and compared them to the pre-radiotherapy PSA level and the outcome of radiotherapy.RESULTS:After radiotherapy, 31 patients (76%) had either undetectable (n = 15), or decreasing but still detectable PSA levels (n = 16) and ten patients (24%) had rising PSA levels and did not respond. PSA evaluation at 30 Gy showed that 26% (8/31) of those patients who would respond to radiotherapy still had a rising PSA when compared to pretreatment PSA. At 50 Gy and 60 Gy 93% (27/29) of these patients had decreasing PSA levels. In contrast, 75% (6/8) and 88% (7/8) of those patients in whom radiotherapy was not effective had rising PSA levels at 50 Gy and 60 Gy (p < 0.05).CONCLUSIONS:PSA measurements at 30 Gy, 50 Gy and 60 Gy for radiotherapy of PSA increase following radical prostatectomy without histologically proven local recurrence gives valuable information about the later tumor response. Therefore it possibly gives the opportunity to finish radiotherapy between 50 and 60 Gy, as almost all patients with continued PSA increase at 60 Gy do not stand to profit from radiotherapy. In these patients dose limitation would significantly decrease the risk of late side effects, especially for the bladder and the rectum. PSA evaluations at 30 Gy and 50 Gy or 60 Gy are recommendable.