At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic stage IV (D2) disease
- ✓Bone metastases of any number allowed, or unequivocal visceral metastases (liver, brain, or lung)
- ✓PSA at least 5 ng/mL
- ✓SWOG performance status 0-2
- ✕Suspected second primary tumors unless histologically confirmed with special stains
- ✕Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, bladder carcinoma in situ, or other superficial cancer
- ✕Prior bilateral orchiectomy
- ✕Concurrent biological response modifier therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
In Brief
A Phase 3 clinical trial evaluating bicalutamide, goserelin acetate, and 1 other intervention for Prostate Cancer. Completed, enrolled 3,040 participants across 14 sites.
Detailed Summary
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.
Study Details
Timeline
Interventions
Given orally
Given subcutaneously
Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.