Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00667069
Brief Summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.
Detailed Description:
OBJECTIVES:
Primary
* Compare the efficacy, in terms of event-free survival at 5 years, of immediate radio-hormonal therapy immediately after prostatectomy for tumor pT2, R1, pN0, or pNx versus radio-hormonal therapy at biochemical relapse.
Secondary
* Compare the overall survival of patients treated with these regimens.
* Compare the metastasis-free survival of these patients.
* Compare the acute and late toxicities of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the functional dependence of patients over 75 years old.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
* Arm I (delayed treatment): Patients receive triptorelin intramuscularly on day 1 and then 3 months later. Patients also undergo conformal radiotherapy daily, 5 days a week, for 7 weeks. Treatment begins at biochemical relapse (PSA is more than 0.2 ng/mL) and before PSA is more than 2 ng/mL.
* Arm II (immediate treatment): Patients receive treatment as in arm I, but treatment begins within 6 months after surgery.
After completion of study treatment, patients are followed for up to 5 years.
Study:
NCT00667069
Study Brief:
Protocol Section:
NCT00667069