Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Procedure: orchiectomyRadiation: radiation therapy
- Registration Number
- NCT00002633
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.
PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall survival, disease specific survival, and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation.
* Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Compare the sensitivity of the EORTC-QLQ-C30+3 and a trial-specific checklist (PR17) with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical \[no CT scan\] vs radiological \[CT scan negative\] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone \[LHRH\] with antiandrogen). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive antiandrogen therapy comprising oral flutamide every 8 hours, oral nilutamide every 8 hours for 1 month and then once daily, or oral bicalutamide once daily. Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously (SC) every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), leuprolide intramuscularly every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), or buserelin SC every 8 weeks or every 12 weeks. Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery (at the physician's discretion).
* Arm II: Patients undergo total androgen ablation as in arm I. Patients with node-negative dissection undergo radiotherapy 5 days a week for 6.5-7 weeks. All other patients undergo radiotherapy 5 days a week for 5 weeks, followed by boost radiotherapy 5 days a week for 2-2.4 weeks.
Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on the last day of radiotherapy, at 6 months, and then every 6 months thereafter.
Patients are followed at 1, 2, and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study within 7.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 361
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Total Androgen Blockade orchiectomy - Total Androgen Blockade leuprolide acetate - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation bicalutamide - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation orchiectomy - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation leuprolide acetate - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation radiation therapy - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation flutamide - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation goserelin - Total Androgen Blockade bicalutamide - Total Androgen Blockade flutamide - Total Androgen Blockade goserelin - Total Androgen Blockade nilutamide - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation nilutamide - Total Androgen Blockade buserelin - Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation buserelin -
- Primary Outcome Measures
Name Time Method Overall survival 10 years
- Secondary Outcome Measures
Name Time Method Quality of life assessed by EORTC-QLQ-C30 + 3 and a trial-specific checklist (PR17) or the FACT-P questionnaire 10 years Disease specific survival 10 years Symptomatic local control measured by surgical intervention rate 10 years Time to disease progression 10 years
Trial Locations
- Locations (15)
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
Thunder Bay Regional Health Science Centre
🇨🇦Thunder Bay, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Ottawa Health Research Institute - General Division
🇨🇦Ottawa, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
Regional Cancer Program of the Hopital Regional
🇨🇦Sudbury, Ontario, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada