At a glance
ClinicalIndex Comparison Record- ✓Histologically proven prostate cancer with high-risk features: either PSA 20-100 ng/mL with Gleason score ≥7, OR clinical stage ≥T2 with Gleason score ≥8 and PSA ≤100 ng/mL
- ✓Negative lymph nodes
- ✓No metastatic disease
- ✓Age over 18 years
- ✕Prior pelvic radiotherapy
- ✕Prior radical prostatectomy
- ✕Prior cryosurgery or orchiectomy for prostate cancer
- ✕Other invasive cancer within past 5 years (except superficial nonmelanomatous skin cancer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating bicalutamide, estramustine phosphate sodium, and 6 other interventions for Prostate Cancer. Completed, enrolled 397 participants across 54 sites in 2 countries.
Detailed Summary
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. 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 radiation therapy is more effective with or without combination chemotherapy for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
Study Details
Timeline
Interventions
Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles
50 mg/m\^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles
Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
135 mg/m\^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles
Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months
Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.
To keep international normalized ratio (INR) \> 1.5 and \< 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy