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
Enfermedades Urogenitales+6
+ Enfermedades Genitales
+ Enfermedades Genitales Masculinas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1997
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 105 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Hombre
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Herbert Irving Comprehensive Cancer Center
New York, United StatesAbrir Herbert Irving Comprehensive Cancer Center en Google Maps