Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00003653
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. It is not yet known which androgen suppression regimen is more effective for prostate cancer.
PURPOSE: This randomized phase III trial is studying two hormone therapy regimens and comparing them to see how well they work in treating patients with rising PSA levels following radiation therapy for prostate cancer.
- Detailed Description
OBJECTIVES:
* Compare the survival of prostate cancer patients with prostate-specific antigen progression in the clinical absence of distant metastases after prior radical radiotherapy treated with intermittent androgen suppression (IAS) vs continuous androgen deprivation (CAD).
* Compare the time to the development of hormone resistance in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Compare the serum cholesterol and HDL/LDL levels at 3 years with those at baseline and compare them annually in patients treated with these regimens.
* Evaluate the duration of treatment and non-treatment intervals, time to testosterone recovery (return to pre-therapy levels), and time to recover potency in patients treated with IAS.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior radical prostatectomy (yes vs no), time since completion of prior radical radiotherapy (1 to 3 years vs 3 years or more), baseline prostate-specific antigen (PSA) value (3-15 ng/mL vs greater than 15 ng/mL), and prior hormonal therapy (neo-adjuvant, concurrent, or adjuvant cytoreduction in association with the radical radiotherapy treatment or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization) (yes vs no). Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo intermittent androgen suppression (IAS). Patients receive luteinizing hormone-releasing hormone (LHRH) analog (buserelin \[BSRL\], goserelin \[ZDX\], or leuprolide \[LEUP\]) and an antiandrogen (nilutamide \[ANAN\], flutamide \[FLUT\], bicalutamide \[CDX\], or cyproterone acetate \[CPTR\]) for 8 months. Patients receive LHRH analog by subcutaneous (SC) or intramuscular (IM) implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily, depending on the actual LHRH analog and antiandrogen. PSA levels are monitored every 2 months. If PSA falls to normal during the 8-month treatment period, therapy stops until levels rise to 10 ng/mL, at which time IAS resumes for another 8-month period. IAS continues as long as PSA levels are controlled. At the time of disease progression, patients begin continuous hormonal treatment similar to arm II.
* Arm II: Patients undergo continuous androgen deprivation without scheduled interruptions. Patients receive LHRH analog (BSRL, ZDX, or LEUP) with an antiandrogen (ANAN, FLUT, CDX, or CPTR) OR undergo bilateral orchiectomy within 5 days of randomization and receive an antiandrogen. Patients receive LHRH analog by SC or IM implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily, depending on the actual LHRH analog and antiandrogen. PSA levels are monitored every 2 months. Treatment continues until hormone resistance develops.
Patients receiving LHRH analog may begin antiandrogen therapy either prior to or simultaneously with LHRH analog and must continue antiandrogen therapy for at least 4 weeks to block tumor flare.
Quality of life is assessed at randomization, every 4 months for 2 years, every 8 months until development of hormone resistance, at the time of hormone resistance, and then annually thereafter.
Patients are followed annually for survival.
PROJECTED ACCRUAL: A total of 1,386 patients will be accrued for this study within 7 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1386
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent Androgen Suppression leuprolide acetate - Continuous Androgen Suppression leuprolide acetate - Intermittent Androgen Suppression bicalutamide - Intermittent Androgen Suppression cyproterone acetate - Intermittent Androgen Suppression flutamide - Intermittent Androgen Suppression goserelin - Continuous Androgen Suppression bicalutamide - Intermittent Androgen Suppression nilutamide - Continuous Androgen Suppression cyproterone acetate - Continuous Androgen Suppression flutamide - Continuous Androgen Suppression goserelin - Continuous Androgen Suppression nilutamide - Intermittent Androgen Suppression buserelin - Continuous Androgen Suppression buserelin -
- Primary Outcome Measures
Name Time Method Overall survival 2 years
- Secondary Outcome Measures
Name Time Method Time to hormone resistance 2 years Serum cholesterol, high-density lipoprotein, and low-density lipoprotein levels 2 years Quality of life by European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire-C30+ (EORTC QLQ-C30+) trial specific checklist 2 years Duration of treatment and non-treatment interval during intermittent androgen suppression arm only 2 years Time to testosterone recovery during intermittent androgen suppression arm only 2 years Time to recovery of potency during intermittent androgen suppression arm only 2 years
Trial Locations
- Locations (29)
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Clinical Research Unit at Vancouver Coastal
🇨🇦Vancouver, British Columbia, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
William Osler Health Centre, Brampton Memorial
🇨🇦Brampton, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
Northeast Cancer Center Health Sciences
🇨🇦Sudbury, Ontario, Canada
Thunder Bay Regional Health Science Centre
🇨🇦Thunder Bay, Ontario, Canada
Ottawa Health Research Institute - General Division
🇨🇦Ottawa, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
The Vitalite Health Network - Dr. Leon Richard
🇨🇦Moncton, New Brunswick, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada