Adjuvant androgen deprivation (ADT) versus mitoxantrone plus prednisone (MP) plus ADT in high-risk prostate cancer (PCa) patients following radical prostatectomy: A phase III intergroup trial (SWOG S9921) NCT00004124.

2017 ◽  
Vol 2017 (1_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
L. Michael Glode ◽  
Catherine M. Tangen ◽  
Maha Hussain ◽  
Gregory P. Swanson ◽  
David Peter Wood ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Intergroup Trial

scholarly journals Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921

2018 ◽  
Vol 36 (15) ◽  
pp. 1498-1504 ◽  
Author(s):  
Maha Hussain ◽  
Catherine M. Tangen ◽  
Ian M. Thompson ◽  
Gregory P. Swanson ◽  
David P. Wood ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Specific Antigen ◽  
Androgen Deprivation ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Adjuvant Radiation ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

Purpose Patients with high-risk prostate cancer after radical prostatectomy are at risk for death. Adjuvant androgen-deprivation therapy (ADT) may reduce this risk. We hypothesized that the addition of mitoxantrone and prednisone (MP) to adjuvant ADT could reduce mortality compared with adjuvant ADT alone. Methods Eligible patients had cT1-3N0 prostate cancer with one or more high-risk factors after radical prostatectomy (Gleason score [GS] ≥ 8; pT3b, pT4, or pN+ disease; GS 7 and positive margins; or preoperative prostate-specific antigen [PSA] > 15 ng/mL, biopsy GS score > 7, or PSA > 10 ng/mL plus biopsy GS > 6. Patients with PSA ≤ 0.2 ng/mL after radical prostatectomy were stratified by pT/N stage, GS, and adjuvant radiation plan and randomly assigned to ADT (bicalutamide and goserelin for 2 years) or ADT plus six cycles of MP. The primary end point was overall survival (OS). Median OS was projected to be 10 years in the ADT arm, requiring 680 patients per arm to detect a hazard ratio of 1.30 with 92% power and one-sided α = .05. Results Nine hundred sixty-one eligible intent-to-treat patients were randomly assigned to ADT or ADT + MP from October 1999 to January 2007, when the Data Safety Monitoring Committee recommended stopping accrual as a result of higher leukemia incidence with ADT + MP. Median follow-up was 11.2 years. The 10-year OS estimates were 87% with ADT (expected 50%) and 86% with ADT + MP (hazard ratio, 1.06; 95% CI, 0.79 to 1.43). The 10-year estimate for disease-free survival was 72% for both arms. Prostate cancer was the cause of death in 18% of patients in the ADT arm and 22% in the ADT + MP arm. More patients in the MP arm died of other cancers (36% v 18% in ADT alone arm). Conclusion MP did not improve OS and increased deaths from other malignancies. The DFS and 10-year OS in these patients treated with 2 years of ADT were encouraging compared with historical estimates, although a definitive conclusion regarding value of ADT may not be made without a nontreatment control arm.

Long-Term Outcome of Patients with High-Risk Prostate Cancer following Radical Prostatectomy and Stage-Dependent Adjuvant Androgen Deprivation

2010 ◽  
Vol 84 (2) ◽  
pp. 164-173 ◽  
Author(s):  
Martin Spahn ◽  
Christel Weiss ◽  
Pia Bader ◽  
Philipp Ströbel ◽  
Elmar W. Gerharz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Androgen Deprivation ◽  
Term Outcome ◽  
Long Term Outcome ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

Prostate-Only Versus Whole-Pelvic Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer (POP-RT): Outcomes From Phase III Randomized Controlled Trial

2021 ◽  
pp. JCO.20.03282
Author(s):  
Vedang Murthy ◽  
Priyamvada Maitre ◽  
Sadhana Kannan ◽  
Gitanjali Panigrahi ◽  
Rahul Krishnatry ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
High Risk ◽  
Controlled Trial ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
Free Survival ◽  
Randomized Controlled ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

PURPOSE We report the clinical outcomes of a randomized trial comparing prophylactic whole-pelvic nodal radiotherapy to prostate-only radiotherapy (PORT) in high-risk prostate cancer. METHODS This phase III, single center, randomized controlled trial enrolled eligible patients undergoing radical radiotherapy for node-negative prostate adenocarcinoma, with estimated nodal risk ≥ 20%. Randomization was 1:1 to PORT (68 Gy/25# to prostate) or whole-pelvic radiotherapy (WPRT, 68 Gy/25# to prostate, 50 Gy/25# to pelvic nodes, including common iliac) using computerized stratified block randomization, stratified by Gleason score, type of androgen deprivation, prostate-specific antigen at diagnosis, and prior transurethral resection of the prostate. All patients received image-guided, intensity-modulated radiotherapy and minimum 2 years of androgen deprivation therapy. The primary end point was 5-year biochemical failure-free survival (BFFS), and secondary end points were disease-free survival (DFS) and overall survival (OS). RESULTS From November 2011 to August 2017, a total of 224 patients were randomly assigned (PORT = 114, WPRT = 110). At a median follow-up of 68 months, 36 biochemical failures (PORT = 25, WPRT = 7) and 24 deaths (PORT = 13, WPRT = 11) were recorded. Five-year BFFS was 95.0% (95% CI, 88.4 to 97.9) with WPRT versus 81.2% (95% CI, 71.6 to 87.8) with PORT, with an unadjusted hazard ratio (HR) of 0.23 (95% CI, 0.10 to 0.52; P < .0001). WPRT also showed higher 5-year DFS (89.5% v 77.2%; HR, 0.40; 95% CI, 0.22 to 0.73; P = .002), but 5-year OS did not appear to differ (92.5% v 90.8%; HR, 0.92; 95% CI, 0.41 to 2.05; P = .83). Distant metastasis-free survival was also higher with WPRT (95.9% v 89.2%; HR, 0.35; 95% CI, 0.15 to 0.82; P = .01). Benefit in BFFS and DFS was maintained across prognostic subgroups. CONCLUSION Prophylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.

Duration of androgen deprivation therapy in high risk prostate cancer: Final results of a randomized phase III trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5008-5008 ◽  
Author(s):  
Abdenour Nabid ◽  
Marie-Pierre Garant ◽  
André-Guy Martin ◽  
Jean-Paul Bahary ◽  
Celine Lemaire ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Androgen Deprivation Therapy ◽  
Cox Regression ◽  
Mixed Linear Model ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
High Risk Prostate Cancer ◽  
Significant Difference ◽  
Risk Prostate Cancer

5008 Background: Long-term androgen deprivation therapy (ADT) combined with radiotherapy (RT) is a standard treatment for patients with high-risk prostate cancer (HRPC). However, the optimal duration of ADT is not yet defined. The aim of this randomized trial (Clinical Trials.gov, #NCT00223171) was to compare outcomes of RT combined with either 36 or 18 months of ADT. Methods: Patients with HRPC were randomized to pelvic and prostate RT combined with 36 (arm 1) or 18 months (arm 2) of ADT. Overall survival (OS) and quality of life (QoL) were primary end points. OS rates were compared with Cox Regression model and QoL data were analyzed through mixed linear model. Results: 630 patients were randomized, 310 to arm 1 and 320 to arm 2. With a median follow-up of 9.4 years, 290 patients had died (147 arm 1 vs. 143 arm 2). The 10-year OS rate was 62.4% (95% confidence interval [CI] 56.4%, 67.8%) for arm 1 and 62.0% (95% CI 56.1%, 67.3%) for arm 2 (p = 0.8412) with a global hazard ratio (HR) of 1.024 (95% CI 0.813-1.289, p = 0.8411). QoL analysis showed a significant difference (p < 0.001) in 6 scales and 13 items favoring 18 months ADT with two of them presenting a clinically relevant difference in mean scores of ≥10 points. Conclusions: In HRPC, ADT combined with RT can be safely reduced from 36 to 18 months without compromising outcomes or QoL. 18 months of ADT represents a new standard of care in HRPC. Funded by AstraZeneca Pharmaceuticals Clinical trial information: NCT00223171.

885 AVOIDING ANDROGEN DEPRIVATION THERAPY IN MEN WITH HIGH RISK PROSTATE CANCER: THE ROLE OF RADICAL PROSTATECTOMY AS INITIAL TREATMENT

2011 ◽  
Vol 185 (4S) ◽  
Author(s):  
Ranko Miocinovic ◽  
Ryan K. Berglund ◽  
Andrew J. Stephenson ◽  
J. Stephen Jones ◽  
Amr F. Fergany ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Androgen Deprivation Therapy ◽  
Initial Treatment ◽  
Androgen Deprivation ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer
Sign in / Sign up

Export Citation Format

Share Document