At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed locally confined adenocarcinoma of the prostate, clinical stage T1b, T1c, T2a, or T2b
- ✓Negative lymph nodes (NX by imaging or N0 by surgical sampling)
- ✓Karnofsky performance status ≥70
- ✓PSA ≤20 ng/mL
- ✕Stage T1a or ≥T2c disease
- ✕Lymph node involvement (N1-N3)
- ✕Evidence of distant metastasis (M1)
- ✕PSA >20
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE III TRIAL OF THE STUDY OF ENDOCRINE THERAPY USED AS A CYTOREDUCTIVE AND CYTOSTATIC AGENT PRIOR TO RADIATION THERAPY IN GOOD PROGNOSIS LOCALLY CONFINED ADENOCARCINOMA OF THE PROSTATE
In Brief
A Phase 3 clinical trial evaluating flutamide, Zoladex, and 2 other interventions for Prostate Cancer. Completed, enrolled 2,028 participants across 239 sites in 2 countries.
Detailed Summary
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
Study Details
Timeline
Interventions
Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.
3.6 mg s.c. monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
7.5 mg IM (intramuscular) monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
46.8 Gy (1.8 Gy/day four to five times a week \[26 fx\]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.