At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage T1-T3 adenocarcinoma of the prostate before radical prostatectomy and lymph node dissection
- ✓Prostatectomy completed within the past 120 days
- ✓At least one high-risk pathologic criterion: Gleason sum ≥8, pT3b/pT4/N1, Gleason 7 with positive margin, or preoperative PSA >15 ng/mL with Gleason >7, or PSA >10 ng/mL with Gleason >6
- ✓Undetectable PSA (≤0.2 ng/mL) documented after surgery or prior to adjuvant hormonal therapy initiation
- ✕Evidence of metastatic disease on bone scan if PSA ≥20 ng/mL at clinical diagnosis
- ✕Distant metastatic disease
- ✕Uncontrolled congestive heart failure
- ✕History of other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I-II cancer in complete remission
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy
In Brief
A Phase 3 clinical trial evaluating bicalutamide, goserelin, and 2 other interventions for Prostate Cancer. Completed, enrolled 983 participants across 234 sites.
Detailed Summary
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.