PURPOSE: We report on the post-radical prostatectomy outcomes of patients enrolled in 3 randomized, multicenter, clinical trials of intense neoadjuvant androgen deprivation therapy prior radical prostatectomy. MATERIALS AND METHODS: All patients included were enrolled in trials evaluating intense androgen deprivation therapy followed by radical prostatectomy. The primary end point was time to biochemical recurrence, defined as the time from radical prostatectomy to prostate specific antigen >0.1 ng/ml or start of first post-radical prostatectomy therapy, stratified by pathological response at radical prostatectomy (presence or absence of exceptional pathological response defined as residual tumor at radical prostatectomy measuring 0-5 mm). Secondary end points included metastasis-free survival, overall survival, and time to testosterone recovery. RESULTS: Overall, 117 patients were included in the analysis, of whom 78.6% (92) had high risk disease. Following neoadjuvant therapy, 21.4% (25) had 0-5 mm of residual tumor, including 9.4% (11) with a pathological complete response. Overall, 49 patients (41.9%) experienced biochemical recurrence and the 3-year biochemical recurrence-free rate was 59.1% (95% CI 49.0-67.9). Of the 25 patients with an exceptional pathological response, 2 patients (8.0%) developed biochemical recurrence while 51.1% of nonresponders (47/92) developed biochemical recurrence. Testosterone recovery was observed in 93.8% of patients (106/113). PTEN loss and intraductal carcinoma were associated with shorter time to biochemical recurrence. CONCLUSIONS: In this pooled analysis of prospective trials, we demonstrate that exceptional pathological response following neoadjuvant therapy is associated with a favorable impact on biochemical recurrence. PTEN loss and intraductal carcinoma were associated with biochemical recurrence. Additional followup is warranted to evaluate the impact on long-term outcomes.
RCT Entities:
PURPOSE: We report on the post-radical prostatectomy outcomes of patients enrolled in 3 randomized, multicenter, clinical trials of intense neoadjuvant androgen deprivation therapy prior radical prostatectomy. MATERIALS AND METHODS: All patients included were enrolled in trials evaluating intense androgen deprivation therapy followed by radical prostatectomy. The primary end point was time to biochemical recurrence, defined as the time from radical prostatectomy to prostate specific antigen >0.1 ng/ml or start of first post-radical prostatectomy therapy, stratified by pathological response at radical prostatectomy (presence or absence of exceptional pathological response defined as residual tumor at radical prostatectomy measuring 0-5 mm). Secondary end points included metastasis-free survival, overall survival, and time to testosterone recovery. RESULTS: Overall, 117 patients were included in the analysis, of whom 78.6% (92) had high risk disease. Following neoadjuvant therapy, 21.4% (25) had 0-5 mm of residual tumor, including 9.4% (11) with a pathological complete response. Overall, 49 patients (41.9%) experienced biochemical recurrence and the 3-year biochemical recurrence-free rate was 59.1% (95% CI 49.0-67.9). Of the 25 patients with an exceptional pathological response, 2 patients (8.0%) developed biochemical recurrence while 51.1% of nonresponders (47/92) developed biochemical recurrence. Testosterone recovery was observed in 93.8% of patients (106/113). PTEN loss and intraductal carcinoma were associated with shorter time to biochemical recurrence. CONCLUSIONS: In this pooled analysis of prospective trials, we demonstrate that exceptional pathological response following neoadjuvant therapy is associated with a favorable impact on biochemical recurrence. PTEN loss and intraductal carcinoma were associated with biochemical recurrence. Additional followup is warranted to evaluate the impact on long-term outcomes.
Authors: Scott Wilkinson; Huihui Ye; Fatima Karzai; Stephanie A Harmon; Nicholas T Terrigino; David J VanderWeele; John R Bright; Rayann Atway; Shana Y Trostel; Nicole V Carrabba; Nichelle C Whitlock; Stephanie M Walker; Rosina T Lis; Houssein Abdul Sater; Brian J Capaldo; Ravi A Madan; James L Gulley; Guinevere Chun; Maria J Merino; Peter A Pinto; Daniela C Salles; Harsimar B Kaur; Tamara L Lotan; David J Venzon; Peter L Choyke; Baris Turkbey; William L Dahut; Adam G Sowalsky Journal: Eur Urol Date: 2021-03-27 Impact factor: 20.096
Authors: John R Bright; Rosina T Lis; Anson T Ku; Nicholas T Terrigino; Nichelle C Whitlock; Shana Y Trostel; Nicole V Carrabba; Stephanie A Harmon; Baris Turkbey; Scott Wilkinson; Adam G Sowalsky Journal: J Urol Date: 2022-03-01 Impact factor: 7.600
Authors: Rakesh Shiradkar; Soumya Ghose; Amr Mahran; Lin Li; Isaac Hubbard; Pingfu Fu; Sree Harsha Tirumani; Lee Ponsky; Andrei Purysko; Anant Madabhushi Journal: Front Oncol Date: 2022-05-20 Impact factor: 5.738
Authors: Gaëtan Devos; Wout Devlies; Gert De Meerleer; Marcella Baldewijns; Thomas Gevaert; Lisa Moris; Daimantas Milonas; Hendrik Van Poppel; Charlien Berghen; Wouter Everaerts; Frank Claessens; Steven Joniau Journal: Nat Rev Urol Date: 2021-09-15 Impact factor: 14.432