Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Consolidation arm I
Active Comparator
Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.
Consolidation arm II
Experimental
Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.
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
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
