Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
flutamide
+ leuprolide acetate
+ radiation therapy
Maladies génito-urinaires+7
+ Maladies Génitales
+ Maladies génitales masculines
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer. Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients. OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV). Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid. Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy. Hormonal therapy is administered until 9 months of treatment have elapsed. Patients will be followed every 3 months for the first year, every 4 months for the second and third years, and every 6 months thereafter. PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3 years, and 58 patients from biologic class III-IV.
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.105 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.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 localized adenocarcinoma of the prostate Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4 CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50 Negative pelvic lymphadenectomy, if PSA is greater than 50 Bone scan negative for metastases or PSA no greater than 20 PATIENT CHARACTERISTICS: Age: Not specified Performance Status: Not specified Life Expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 70,000/mm3 Hemoglobin at least 10 g/dL Patients on anticoagulant therapy must have a baseline PT test Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) ALT or AST less than 1.5 times ULN Alkaline phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.5 times ULN Cardiovascular: No history of collagen vascular disease Other: No acute infection requiring antibiotics No history of hypersensitivity to flutamide No history of hypersensitivity to leuprolide acetate PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
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 1 site
Herbert Irving Comprehensive Cancer Center
New York, United StatesOuvrir Herbert Irving Comprehensive Cancer Center dans Google Maps