Efficacité et tolérance comparées de la Combinaison radiothérapie-hormonothérapie Adjuvante et de l'hormonothérapie Seule Dans Les Cancers de la Prostate Localement évolués (T3-T4 ou pT3 Biopsiques,N0, M0)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
5 year progression free survival
After 5 years median follow up of patients
Yes
Nicolas MOTTET, Dr
Principal Investigator
Clinique Mutualiste - Saint-Etienne
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
TAP III/98/032
NCT01122121
March 2000
June 2009
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