NRG-GU008 Prostate Cancer - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find out if an investigational drug called apalutamide (the study drug) is a safe and effective treatment for your form of cancer. We want to know how well people respond to the usual therapy (hormone therapy and radiation) in combination with the study drug compared to the usual therapy on its own.
¿Cuál es la Condición que se está estudiando?
Node-Positive Prostate Cancer after Radical Prostatectomy
¿Quién puede participar en el Estudio?
Adults ages 18+ who:
- Are diagnosed with prostate adenocarcinoma
- Have pathologically node positive disease with nodal involvement only in the pelvis in the
prostatectomy specimen
For more information about who can join this study, please contact the study team at brant.inman@duke.edu.
Grupo etario
Adultos
¿Qué Implica?
Si decide unirse a este estudio, se le asignará al azar (como si se lanzara una moneda al aire) a 1 de 2 grupos:
- One group will get the standard hormone drugs for up to 24 months plus radiation therapy for 5-8 weeks
- The other group will get the standard hormone drugs for up to 24 months, radiation therapy for 5-8 weeks, and the study drug for 24 months
Detalles del Estudio
Título Completo
NRG-GU008, Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer after Radical Prostatectomy (INNOVATE*)
Investigador Principal
Especialista en oncología radioterápica
Número de Protocolo
IRB:
PRO00112257
NCT:
NCT04134260
Fase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción