SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed adenocarcinoma of the prostate
• •* Metastatic stage IV (stage D2)
• •* Any number of bone metastases by bone scan allowed
• •* Unequivocal visceral organ metastases (liver, brain, or lung) allowed
• •* No suspected second primary tumors unless metastases are histologically confirmed, including special stains (e.g., prostate specific antigen \[PSA\] and prostatic alkaline phosphatase \[PAP\])
• •For entry into late induction therapy:
• •* No more than 1 month from the beginning of antiandrogen therapy to the beginning of luteinizing hormone-releasing hormone (LHRH) agonist therapy
• •* No more than 6 months since initiation of current combined androgen-deprivation therapy (LHRH agonist and antiandrogen)
• •* The effectiveness of the current depot LHRH agonist would not extend beyond 8 months after initiation of combined androgen therapy
• •PSA at least 5 ng/mL
• •No acute spinal cord compression
• •PATIENT CHARACTERISTICS:
• •Age:
• •Adult
• •Performance status:
• •SWOG 0-2
• •Hematopoietic:
• •Not specified
• •Hepatic:
• •Not specified
• •Renal:
• •Not specified
• •Other:
• •Recovered from any major infection
• •No active medical illness that would preclude study or limit survival
• •No other malignancy within the past 5 years except:
• •* Adequately treated basal cell or squamous cell skin cancer
• •* Adequately treated carcinoma in situ of the bladder
• •* Adequately treated other superficial cancer
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No concurrent biological response modifier therapy
• •Chemotherapy:
• •No concurrent chemotherapy
• •Endocrine therapy:
• •See Disease Characteristics
• •More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of no more than 4 months
• •* Single or combination therapy allowed
• •More than 1 year since prior finasteride for prostate cancer for a duration of no more than 9 months (less than 6 months for benign prostatic hypertrophy)
• •Prior or concurrent megestrol for hot flashes allowed
• •No other concurrent hormonal therapy
• •Radiotherapy:
• •No concurrent radiotherapy other than palliation of painful bone metastases
• •Surgery:
• •No prior bilateral orchiectomy
• •Recovered from any prior major surgery