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
Maladies génito-urinaires+7
+ Maladies Génitales
+ Maladies génitales masculines
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1997
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.450 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Homme
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 23 sites
Centre Hospitalier d'Annecy
Annecy, FranceInstitut Bergonie
Bordeaux, FranceCentre Regional Francois Baclesse
Caen, France