A Phase 3 interventional study of flutamide and triptorelin in Prostate Cancer, sponsored by UNICANCER. Completed at 31 sites in France. Open to male participants aged 0 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by UNICANCER · Phase 3, Interventional, and Treatment
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 378 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer, meeting the following clinical staging criteria:
No lymph node invasion (N0 or N-)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Radiation: radiation therapy
Drug: flutamide · Drug: triptorelin · Radiation: radiation therapy
Impact of complete androgen blockade for 4 months
Survival, in terms of clinical or biological remission, at 5 years
Overall survival
Acute and late toxicity
Quality of life
Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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