Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial (NCT04134260)
🩺 Plain-English Summary (8th-Grade Level)
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (22 items).
Location: Cancer Center at Saint Joseph's — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. Fluciclovine F-18 PET, \[FACBC, Axumin\], F-18 PSMA PET \[Pylarify\], flotufolastat F-18 PSMA PET scan \[Posluma\], Gallium-68 PSMA PET scan or C-11 choline PET)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed \> 3 years prior to registration)
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Androgen deprivation therapy (ADT) prior to radical prostatectomy
- Prior treatment with androgen receptor signaling inhibitor (including but not exclusive to a growing list of: abiraterone acetate, enzalutamide, apalutamide, darolutamide), unless started =\< 180 days and stopped prior to registration, which is allowed
- Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
- History of any of the following:
- Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)
- Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration
- New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification.)
- History of any condition that in the opinion of the investigator, would preclude participation in this study
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (350 Sites)
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Kaiser Permanente-Anaheim — Anaheim, California
- Kaiser Permanente-Baldwin Park — Baldwin Park, California
- Kaiser Permanente-Bellflower — Bellflower, California
- Mercy Cancer Center - Carmichael — Carmichael, California
- Mercy San Juan Medical Center — Carmichael, California
- Mercy Cancer Center - Elk Grove — Elk Grove, California
- Kaiser Permanente-Fontana — Fontana, California
- Marin General Hospital — Greenbrae, California
- Kaiser Permanente South Bay — Harbor City, California
- Kaiser Permanente-Irvine — Irvine, California
- Tibor Rubin VA Medical Center — Long Beach, California
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Kaiser Permanente West Los Angeles — Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
- Kaiser Permanente-Ontario — Ontario, California
- Kaiser Permanente - Panorama City — Panorama City, California
- Kaiser Permanente-Riverside — Riverside, California
- Mercy Cancer Center - Rocklin — Rocklin, California
- Mercy Cancer Center - Sacramento — Sacramento, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Kaiser Permanente-San Diego Zion — San Diego, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.