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

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

Detailed Description
-----------------
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.

Official Title
-----------------
Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: 3-dimensional conformal radiation therapy
* Radiation: intensity-modulated radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks. | Radiation: 3-dimensional conformal radiation therapy<br>* Patients undergo radiotherapy<br>Radiation: intensity-modulated radiation therapy<br>* Patients undergo radiotherapy<br>|
| Experimental: Arm II<br>Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks. | Radiation: 3-dimensional conformal radiation therapy<br>* Patients undergo radiotherapy<br>Radiation: intensity-modulated radiation therapy<br>* Patients undergo radiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical or clinical progression-free survival at 5 years |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and specific survival |  | 10 years | 
| Acute and late toxicity |  | 10 years | 
| Quality of life as measured by QLQ-C30 and PR 25 questionnaires |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer