Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer

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.

Inclusion criteria

• Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
• pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
• PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
• May receive treatment within 6 months after surgery
• Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
• pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
• No current clinical or biochemical progressive disease
• Life expectancy ≥10 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patient must be affiliated to the social security system
• Patient must have received the information sheet and signed the consent form

Exclusion criteria

• Patient with prostate cancer other than adenocarcinoma
• Gleason score ≥8 and with seminal vesicles involved
• pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
• pT2 disease
• Prior surgical or chemical castration
• Prior hormonal therapy
• Prior radiotherapy within 3 months after radical prostatectomy
• Prior pelvic radiotherapy
• No history of cancer (except basal cell skin cancer) within 5 years of surgery
• No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
• Known hypersensitivity to gonadotropin-releasing hormone or its analogs
• Contraindication to intramuscular injection
• Concurrent participation in another interventional study
• Patients under protective custody or guardianship, unable to comply with the specific requirements of the study or unable to understand the purpose of the study