Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)

Criteria the registry did not label

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the prostate
  • Unfavorable disease, defined by at least 1 of the following criteria:
  • Clinical stage T3 or T4
  • Gleason score ≥8
  • Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL
• pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy
• No pelvic lymph nodes ≥15 mm by CT scan or MRI
• No axillary lymph node involvement (pN1)
• No bone metastasis
• Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy
  • PATIENT CHARACTERISTICS:
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy \>5 years
• Must be enrolled in a social security program
• No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
• No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg)
• No contraindication to luteinizing hormone-releasing hormone agonists
• No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
• No hip prosthesis
• Must not be deprived of liberty or under guardianship
• No geographical, social, or psychological reasons that would preclude follow up
  • PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior pelvic irradiation
• At least 3-4 months since prior transurethral resection
• No other prior surgery for prostate cancer
• No concurrent participation in another clinical trial which would require approval upon entry to this trial