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

OBJECTIVES:

Primary

• Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.

Secondary

• Evaluate overall and specific survival.
• Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).
• Evaluate toxicities of the different doses with respect to hormonal therapy.
• Assess the quality of life (QLQ-C30 and PR 25).

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
• Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.

In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3 years.

After completion of study treatment, patients are followed up periodically for 10 years.

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