Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
18 Years
N/A
Male
Prostate Cancer
Trial Information
Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
OBJECTIVES:
Primary
- Compare the survival of patients with metastatic stage IV prostate cancer responsive to
combined androgen-deprivation therapy (CAD) treated with intermittent vs continuous
CAD.
- Compare the effects of these treatment regimens on impotence, libido, and
vitality/fatigue as well as the physical and emotional well-being of these patients.
Secondary
- Compare general symptoms, role functioning, global perception of quality of life, and
social functioning of patients treated with these regimens.
- Assess prostate-specific antigen (PSA) levels after continuous CAD administered before
randomization and evaluate PSA changes throughout randomized treatment of these
patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to SWOG
performance status (0-1 vs 2), severity of disease (minimal vs extensive), and prior
hormonal therapy (neoadjuvant hormonal therapy vs finasteride vs neither).
- Induction therapy: Patients receive combined androgen-deprivation (CAD) therapy
comprising goserelin subcutaneously once a month and oral bicalutamide once daily for 8
courses (7 months).
- Consolidation therapy: Patients are randomized to 1 of 2 consolidation regimens.
- Arm I (continuous CAD therapy): Patients continue CAD therapy as in induction
therapy. Treatment continues in the absence of disease progression.
- Arm II (intermittent CAD therapy): 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
induction therapy. Patients whose PSA normalizes after 8 courses return to
observation. Patients whose PSA does not normalize after 8 courses continue CAD
therapy.
Quality of life is assessed before induction therapy, at 3 months (before consolidation
therapy), and then at 9 and 15 months.
Patients are followed every 6-12 months for at least 10 years.
PROJECTED ACCRUAL: Approximately 1,500 patients will be accrued for this study.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment-specific symptoms as measured on the four-item Medical Outcomes Study Short Form-36 (SF-36) and Vitality scale
Safety Issue:
No
Principal Investigator
Maha Hadi A. Hussain, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
Unspecified
Study ID:
CDR0000064184
NCT ID:
NCT00002651
Start Date:
May 1995
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IV prostate cancer
- recurrent prostate cancer
- Prostatic Neoplasms
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