S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00004124
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall and disease-free survival of patients with high-risk adenocarcinoma of the prostate treated with adjuvant androgen deprivation therapy with or without mitoxantrone and prednisone after radical prostatectomy.
* Compare the qualitative and quantitative toxic effects of these regimens in this patient population.
* Compare the prostate-specific antigen (PSA) progression-free survival rate in patient treated with these regimens.
* Determine whether PSA progression is a surrogate endpoint for survival or disease-free survival in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to surgical extent of disease (organ confined vs not organ confined, but N0 vs N1), Gleason's sum (less than 7 vs 7 vs greater than 7), and planned radiotherapy (yes vs no). Patients are randomized to one of two treatment arms.
* Arm I:Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
* Arm II:Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
Patients may undergo radiotherapy 5 days a week for 6.5-7.8 weeks beginning anytime (arm I) or after completion of chemotherapy (arm II), at the discretion of the physician, in the absence of disease progression or unacceptable toxicity.
Patients are offered the possibility to participate in biomarker research by allowing their tissue/blood to be studied.
Patients are followed every 6 months for 2 years and then annually for up to 13 years.
PROJECTED ACCRUAL: A total of 1,360 patients (680 per treatment arm) will be accrued for this study within 9.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 983
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bicalutamide, goserelin, mitoxantrone, prednisone bicalutamide androgen deprivation plus mitoxantrone, prednisone bicalutamide, goserelin, mitoxantrone, prednisone mitoxantrone hydrochloride androgen deprivation plus mitoxantrone, prednisone bicalutamide, goserelin, mitoxantrone, prednisone prednisone androgen deprivation plus mitoxantrone, prednisone bicalutamide, goserelin bicalutamide androgen deprivation bicalutamide, goserelin goserelin androgen deprivation bicalutamide, goserelin, mitoxantrone, prednisone goserelin androgen deprivation plus mitoxantrone, prednisone
- Primary Outcome Measures
Name Time Method Disease Free Survival at 10 Years Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact.
Overall Survival at 10 Years Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.
- Secondary Outcome Measures
Name Time Method Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients Up to 22 months from registration Number of patients with adverse events that are related to study drug
PSA Progression Free Survival Up to 10 Years Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of \> 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3.
PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival Up to 10 Years
Trial Locations
- Locations (231)
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Banner Thunderbird Medical Center
🇺🇸Glendale, Arizona, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Highlands Oncology Group - Springdale
🇺🇸Springdale, Arkansas, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
California Cancer Care, Incorporated
🇺🇸Greenbrae, California, United States
Scroll for more (221 remaining)Alaska Regional Hospital Cancer Center🇺🇸Anchorage, Alaska, United States