At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate within 180 days of randomization
- ✓Intermediate-risk disease by one of three specified combinations of clinical stage, Gleason score, and PSA
- ✓ECOG performance status 0-1
- ✓Clinically negative regional lymph nodes (N0) by imaging or negative by nodal sampling/dissection
- ✕High-risk disease (PSA ≥20 AND Gleason ≥7, or clinical stage ≥T2 AND Gleason ≥8)
- ✕Low-risk disease (clinical stage ≤T2, Gleason ≤6, PSA ≤10)
- ✕Clinical stage Tx, T0, or T1a
- ✕Regional lymph node involvement (N1) or metastatic disease (M1)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Casodex, Eulexin, and 2 other interventions for Prostate Cancer. Completed, enrolled 1,579 participants across 261 sites in 2 countries.
Detailed Summary
RATIONALE: Hormones can stimulate the growth 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. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
Study Details
Timeline
Interventions
Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.
Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.
LHRH agonist of choice. The manufacturer's instructions should be followed.
\[Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)\] OR \[regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin\]