Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

• Status: Completed
• Trial end date: 2013-01-10
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborators: National Cancer Institute (NCI); Southwest Oncology Group
• Treatments: Androgens; Bicalutamide; Buserelin; Cyproterone; Cyproterone Acetate; Flutamide; Goserelin; Hormones; Leuprolide; Nilutamide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven adenocarcinoma of the prostate prior to the initiation of radiotherapy

• Prior pelvic radiotherapy for prostate cancer, either post-radical prostatectomy or as primary management

• More than 30 months since prior brachytherapy with curative intent

• Prostate-specific antigen must be rising and greater than 3 ng/mL and higher than the lowest level recorded previously since the end of radiotherapy (i.e., higher than the post-radiotherapy nadir)

• Total testosterone greater than 5 nmol/L

• No definite evidence of metastatic disease

• Chest x-ray and bone scan negative for metastases

• Radiological changes compatible with nonmalignant diseases allowed

• Clinical evidence of local disease allowed

PATIENT CHARACTERISTICS:

Age:

• 16 and over (18 and over for participating centers in the United Kingdom)

Performance status:

• ECOG 0-1

Life expectancy:

• More than 5 years

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST/ALT no greater than 1.5 times ULN

• LDH no greater than 1.5 times ULN

• No chronic liver disease

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Sufficiently fluent and willing to complete the quality of life questionnaire in either English or French

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior or concurrent biologic therapy

Chemotherapy:

• No prior or concurrent chemotherapy

Endocrine therapy:

• Prior hormonal therapy administered prior to, during, or immediately after radical radiotherapy or prostatectomy allowed provided duration was no longer than 12 months

• At least 12 months since prior hormonal therapy

Radiotherapy:

• See Disease Characteristics

• At least 12 months since prior radiotherapy

• No concurrent palliative radiotherapy

Surgery:

• See Disease Characteristics

• See Endocrine therapy

Other:

• No concurrent bisphosphonates