At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate cancer at high-risk for recurrence, meeting one of four risk group criteria (e.g., Gleason ≥9 with PSA ≤150; Gleason 8 with PSA 20-150; Gleason 7 with PSA 20-150)
- ✓Diagnosis within past 180 days
- ✓Clinically negative lymph nodes by imaging (CT/MRI), sampling, or dissection within 90 days; equivocal nodes ≤1.5 cm allowed
- ✓No distant metastases on physical exam and bone scan
- ✕Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
- ✕Prior systemic chemotherapy for prostate cancer
- ✕Prior radiotherapy to prostate region that would result in overlap of treatment fields
- ✕Unstable angina or congestive heart failure requiring hospitalization within past 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Dexamethasone, Prednisone, and 4 other interventions for Prostate Cancer. Completed, enrolled 612 participants across 254 sites in 2 countries.
Detailed Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
Study Details
Timeline
Interventions
Premedication of dexamethasone prior to docetaxel, per institutional standards.
10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.
75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.
Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.
46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.
LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.