At a glance
ClinicalIndex Comparison Record- ✓Pathologically proven prostate adenocarcinoma with Gleason ≥7 and post-operative PSA nadir >0.2 ng/ml (any pT), OR Gleason ≥8 with PSA nadir ≤0.2 ng/ml and ≥pT3a
- ✓Radical prostatectomy completed within the past year
- ✓PSA obtained within 6 weeks prior to registration
- ✓No regional lymph node involvement or distant metastases (N0, M0)
- ✕Other invasive malignancy within past 3 years (except non-melanomatous skin cancer)
- ✕Active, severe comorbidity including unstable angina, CHF requiring hospitalization, MI, active infection, COPD exacerbation, or AIDS within past 6 months
- ✕Prior systemic chemotherapy for prostate cancer
- ✕Prior androgen deprivation for treatment of prostate cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial
In Brief
A Phase 2 clinical trial evaluating bicalutamide, docetaxel, and 4 other interventions for Prostate Cancer. Completed, enrolled 80 participants across 70 sites in 2 countries.
Detailed Summary
RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.
Study Details
Timeline
Interventions
50 mg (one tablet) daily orally for 6 months, starting within 6 months after registration
75 mg/m2 IV over 1 hour on day 1 of each cycle q21 days for 6 cycles, starting 3-6 weeks after completion of radiation therapy
250 mg (two 125-mg capsules) three times daily (total 750 mg) orally for 6 months, starting within 6 months after registration
LHRH agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 6 months, starting within 6 weeks after registration
66.6 Gy (1.8 Gy per fraction, 5 days per week) to the prostate bed (IMRT or 3DCRT), starting 8 weeks after start of hormones