NRG-GU008

Open to Accrual

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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

Open to Accrual

March 5, 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/antagonist
with apalutamide for patients with pathologic node-positive prostate cancer
after 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

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.