NCT04134260PHASE3RECRUITING

Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial

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

Sponsor: NRG Oncology + National Cancer Institute (NCI)

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

Interventions

Apalutamide, Biospecimen Collection, Bone Scan, Computed Tomography

Enrollment

586 participants

Primary completion

Nov 2026

Study completion

Nov 2026

First posted

Oct 2019

Last updated

May 2026

Primary Endpoints (CT.gov)

Metastasis-free survival (MFS)

Time frame: From randomization to detection of metastatic disease or death from any cause, assessed up to 7.5 years

Secondary Endpoints

Quality of life (QOL) between the two treatment arms

Overall survival (OS)

Biochemical progression-free survival (bPFS)

Eligibility Criteria

Inclusion Criteria: * Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted * Any T-stage is eligible (American Joint Committee on Cancer \[AJCC\] 8th edition \[ed\]) * Appropriate stage for study entry based on fluciclovine F-18 PET scan (FACBC, Axumin) F-18 prostate-specific membrane antigen (PSMA) PET (PyLarify) scan, Gallium-68 PSMA PET scan, flotufolastat F-18 PSMA PET scan (Posluma), or C-11 or F-18 Choline PET within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease. For patients with PSA \< 0.20 ng/mL at time of registration, PET scan is recommended but not required * Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen or nodal disease on imaging at time of recurrence (including external iliacs, internal iliacs, and/or obturator nodes); per…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov