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the purpose of this study "Leuprorelin associated with radiotherapy versus leuprorelin alone in T3 - T4 or pT3 (on biopsy) N0, M0 prostate cancer" is to assess the possible benefits of the combined treatment on the local or systemic recurrences and on quality of life.
STUDY DESIGN :
French multicenter, open, randomized study on 2 parallel groups
First step : treatment during 3 years (excepted disease progression) with Leuprorelin 11,25 mg SR + radiotherapy 70 +/- 4 Grays(begun within 90 days after 1st leuprorelin injection) in the first arm and Leuprorelin 11,25 mg SR alone for the 2nd arm. A visit / 6 months.
Second step : follow-up without treatment during 2 years (excepted disease progression). A visit / 6 months.
Third step : Follow-up out of protocol. 1 data collection / year.
End of study when median follow-up = 5years.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Leuprorelin 11,25 mg SR, Radiotherapy + hormonotherapy
Published on BioPortfolio: 2014-08-27T03:13:46-0400
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