Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy
Principal Investigator
Ronald Chen, MD MPH
Status
Open to Accrual
Date Opened To Accrual
March 05 2020
Disease Site
Genitourinary [GU]
Prostate
Phase
III
Developmental Therapeutics
Yes
Primary Objective
Primary Objective: Compare metastasis-free survival(MFS) of salvage RT and GnRH agonist/antagonist vs. RT/ GnRH agonist/antagonistwith apalutamide for patients with pathologic node-positive prostate cancerafter radical prostatectomy with detectable PSA.
Secondary Objectives:
Compare health-related quality of life (EPIC-26, EQ-5D-5L, Brief Pain Inventory, PROMIS-Fatigue) among the treatment arms.
Compare overall survival, biochemical progression-free survival, time to local-regional progression, time to castrate resistance, and cancer-specific survival among the treatment arms.
Compare the short-term and long-term treatment-related adverse events among the treatment arms.
NRG-GU008 / NRG-GU009 Study Update Webinar
Watch Recording
Patient Population
Pathologic node-positive prostate cancer patients after radical prostatectomy and currently having a detectable PSA.
Target Accrual
586