Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.
- 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.
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Event-free survival (clinical progression, biochemical progression, death) at 5 years
Pierre Richaud, MD