Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
radiation therapy
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: December 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis. Compare the toxic effects of these two regimens in these patients. Compare the quality of life of patients treated with these regimens. Determine the prognostic factors of progression in these patients. Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis). Patients are randomized to one of two treatment arms. Arm I: Patients receive pelvic irradiation plus local prostate irradiation. Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks. Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter. Patients are followed at 2 and 6 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.450 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Until 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate Stage I (T1b or T1c, N0, M0) Stage II (T2, N0, M0) Stage III (T3, N0, M0) Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria: Gleason score at least 7 Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN) T3 OR Good prognosis defined as meeting 1 of the following criteria: T1b or T2 T1c with Gleason score less than 7 and PSA less than 3 times ULN No metastases by bone scans or chest x-ray PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Karnofsky 70-100% Life expectancy: More than 10 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 10 years except basal cell skin cancer No adenopathies PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months No concurrent luteinizing hormone-releasing hormone agonists No concurrent anti-androgen therapy No concurrent hormonal therapy in high-risk group Radiotherapy: No prior pelvic radiotherapy Surgery: No prior lymphadenectomy No prior surgical castration No prior prostatectomy At least 1 month since prior transurethral resection
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 23 locations
Centre Hospitalier d'Annecy
Annecy, FranceInstitut Bergonie
Bordeaux, FranceCentre Regional Francois Baclesse
Caen, France