BrUOGPR255A Phase I Study of Dasatinib, Androgen Deprivation Therapy and Radiation For Intermediate and High Risk Prostate Cancer
Dasatinib
Enfermedades Urogenitales+6
+ Enfermedades Genitales
+ Enfermedades Genitales Masculinas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 2013
Fecha en la que se inscribió al primer participante.Radiation and androgen deprivation is a common modality for patients with localized prostate cancer. Unfortunately for patients with intermediate to high risk prostate cancer incomplete tumor eradication and subsequent relapse occurs in 50-75% of patients. The Src pathway appears to be integral to the pathobiology of prostate cancer and may be fundamental to radioresistance. The primary objective of this trial will be to establish the safety of dasatinib with androgen deprivation and radiation for prostate cancer. Three dasatinib dose levels will be evaluated, 50 mg/day, 70 mg/day and 100 mg/day. Dasatinib will begin with day #1 of radiation and will be discontinued once radiation is completed. The study treatment period, therefore, will be when patients receive concurrent dasatinib, hormone therapy and radiation to 30 days after the last radiation/dasatinib treatment. However, it will be highly recommended that, prior to entering the study, patients receive 2 months of androgen deprivation with a LHRH agonist. Furthermore, it will be highly recommended that, after completion of dasatinib /hormone therapy/radiation, patients with intermediate risk disease receive approximately 2 additional months of hormone therapy (to complete 6 months of hormone therapy) and patients with high risk disease receive 20 additional months of ADT to complete 2 years of hormone therapy. If casodex was given at onset of diagnosis, patient must be off drug for 6 weeks prior to beginning radiation therapy
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios