Docetaxel, estramustine, and short-term androgen withdrawal for patients with biochemical failure after definitive local therapy for prostate cancer

2001 ◽  
Vol 28 (4M) ◽  
pp. 32-39 ◽  
Author(s):  
Mary-Ellen Taplin ◽  
Glenn J. Bubley ◽  
Barur Rajeshkumar ◽  
Todd Shuster ◽  
Yoo-Joung Ko ◽  
...  
2019 ◽  
Vol 37 (3) ◽  
pp. 213-221 ◽  
Author(s):  
James J. Dignam ◽  
Daniel A. Hamstra ◽  
Herbert Lepor ◽  
David Grignon ◽  
Harmar Brereton ◽  
...  

Background In prostate cancer, end points that reliably portend prognosis and treatment benefit (surrogate end points) can accelerate therapy development. Although surrogate end point candidates have been evaluated in the context of radiotherapy and short-term androgen deprivation (AD), potential surrogates under long-term (24 month) AD, a proven therapy in high-risk localized disease, have not been investigated. Materials and Methods In the NRG/RTOG 9202 randomized trial (N = 1,520) of short-term AD (4 months) versus long-term AD (LTAD; 28 months), the time interval free of biochemical failure (IBF) was evaluated in relation to clinical end points of prostate cancer–specific survival (PCSS) and overall survival (OS). Survival modeling and landmark analysis methods were applied to evaluate LTAD benefit on IBF and clinical end points, association between IBF and clinical end points, and the mediating effect of IBF on LTAD clinical end point benefits. Results LTAD was superior to short-term AD for both biochemical failure (BF) and the clinical end points. Men remaining free of BF for 3 years had relative risk reductions of 39% for OS and 73% for PCSS. Accounting for 3-year IBF status reduced the LTAD OS benefit from 12% (hazard ratio [HR], 0.88; 95% CI, 0.79 to 0.98) to 6% (HR, 0.94; 95% CI, 0.83 to 1.07). For PCSS, the LTAD benefit was reduced from 30% (HR, 0.70; 95% CI, 0.52 to 0.82) to 6% (HR, 0.94; 95% CI, 0.72 to 1.22). Among men with BF, by 3 years, 50% of subsequent deaths were attributed to prostate cancer, compared with 19% among men free of BF through 3 years. Conclusion The IBF satisfied surrogacy criteria and identified the benefit of LTAD on disease-specific survival and OS. The IBF may serve as a valid end point in clinical trials and may also aid in risk monitoring after initial treatment.


Cancer ◽  
2011 ◽  
Vol 118 (17) ◽  
pp. 4139-4147 ◽  
Author(s):  
J. Paul Monk ◽  
Susan Halabi ◽  
Joel Picus ◽  
Arif Hussain ◽  
George Philips ◽  
...  

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15171-e15171
Author(s):  
Andre Luis de Castro Abreu ◽  
Sanket Chauhan ◽  
Adrian Stuart Fairey ◽  
Ignacio Camacho ◽  
Alvin Goh ◽  
...  

e15171 Background: The safety and feasibility of salvage robot-assisted radical prostatectomy (sRARP) for recurrent prostate cancer is unclear. Herein we report short-term cancer control, functional, and perioperative outcomes in a multi-institutional cohort. Methods: Between July 2007 and October 2011, 38 consecutive men underwent sRARP for recurrent prostate cancer at the University of Southern California (n=14) or Global Robotics Institute (n=24). Failed primary therapy was varied (external beam radiotherapy [EBRT; n=14]; interstitial brachytherapy [IBT; n=11]; EBRT + IBT [n=5]; high-intensity focused ultrasound [n=3]; cryoablation [n=3]; other [n=2]). The main outcomes were immediate biochemical failure (IBF), positive surgical margins (PSM), urinary continence and erectile function at 3 months, and complications within 90 days of surgery. Immediate biochemical failure was defined as a PSA > 0.2 ng/ml. Urinary continence was defined as the use of no pads and erectile function was defined as a SHIM score > 21. Complications were classified and graded using the Clavien system. Results: The median age was 68 years (50-83 years) and median preoperative PSA was 4.1 ng/ml (0.4-15.2 ng/ml). Preoperative biopsy Gleason score was ≤6 (n=7), 7 (n=18), and ≥8 (n=12). All procedures were completed without the need for open conversion. No patient experienced an intra-operative complication. Median estimated blood loss was 100 ml (30-300 ml) and operative time was 1.5 h (1-6h). Median length of hospital stay was 1 day (1-7 days). The median duration of urethral catheterization was 12 days (4-48 days). IBF occurred in 9 (29%) patients and PSM occurred in 7 (18%) patients. Urinary continence and erectile function occurred in 9 (34%) and 0 patients, respectively. One or more postoperative complications occurred in 12 (31%) patients. Low grade (I-II) and high grade (III-IV) complications occurred in 8 (21%) and 4 (10%) patients, respectively. No patient died. Conclusions: Salvage robot-assisted radical prostatectomy is safe and feasible. Short-term cancer control and perioperative morbidity were acceptable; however, functional recovery was poor. To date, this is the largest series worldwide.


2008 ◽  
Vol 179 (3) ◽  
pp. 906-910 ◽  
Author(s):  
Toni K. Choueiri ◽  
Robert Dreicer ◽  
Alan Paciorek ◽  
Peter R. Carroll ◽  
Badrinath Konety

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 5-5 ◽  
Author(s):  
Abdenour Nabid ◽  
Nathalie Carrier ◽  
Eric Vigneault ◽  
Luis Souhami ◽  
Céline Lemaire ◽  
...  

5 Background: The place of short term androgen deprivation therapy (STADT) in combination with radiation therapy (RT) for patients with intermediate risk prostate cancer (IRPC) remains controversial. The purpose of this prospective, randomized trial was to compare outcomes between patients with IRPC treated with different doses of RT with or without STADT, (PCS III trial, Clinical Trials.gov, NCT00223145). Methods: From December 2000 to September 2010, 600 patients with IRPC were randomized to 6 months of STADT and two levels of prostate RT doses of 70 (arm 1) or 76 Gy (arm 2) versus prostate dose-escalated RT alone at 76 Gy (arm 3). STADT consisted of bicalutamide and gosereline for six months. RT (2 Gy per fraction) started four months after the beginning of STADT. Biochemical failure and disease-free survival (DFS) were primary end-points, with overall survival (OS) as secondary endpoint. DFS and OS rates were estimated with Kaplan-Meier and compared with log rank test and Cox regression. Results: Patient’s characteristics were well balanced among the 3 arms (median age 71 years, median PSA 10 ng/ml, median Gleason score 7). At a median follow-up of 75.4 months, biochemical failure occurred in 84 (14%) patients (arms 1 to 3: 12.5%, 8.0%, 21.5%) with statistical difference between arm 1 and 3 (p = 0.023) and arm 2 and 3 (p < 0.001). There was no significant difference between arm 1 and 2. A total of 113 (19%) patients had died with only 6 deaths (1%) attributed to prostate cancer. The 5-/10-year DFS rates were 93%, 97.5% and 86%, and 77%, 90% and 64.5%, respectively. Significant differences in DFS between the treatment arms were observed at 5 years but at 10 years it was observed only between arm 1 and 3 (p=0.01) and arm 2 and 3 (p<0.001). The 5-/10-year OS rates were 91%, 95% and 93%, and 64%, 70% and 78%, respectively. There was no statistical difference in OS between arms at 5 and 10 years. Conclusions: In patients with IRPC, the use of STADT in association with RT, even at lower doses, leads to a superior biochemical control and DFS as compared to dose-escalated RT alone. These outcomes did not translate into an improved OS. Source of Funding: AstraZeneca Pharmaceuticals Grant. Clinical trial information: NCT00223145.


2007 ◽  
Vol 177 (4S) ◽  
pp. 222-222
Author(s):  
Mireia Musquera ◽  
Maria J. Ribal ◽  
Yolanda Arce ◽  
Humberto Villavicencio ◽  
Fernando Algaba ◽  
...  

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