OncoMatch/Clinical Trials/NCT04134260
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
Is NCT04134260 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Apalutamide and Hormone Therapy for prostate adenocarcinoma.
Treatment: Apalutamide · Hormone Therapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage I, II, III, IVA (AJCC v8)
Any T-stage is eligible (American Joint Committee on Cancer [AJCC] 8th edition [ed]); Appropriate stage for study entry based on ... PET scan ... negative for distant metastatic (M1a, M1b, M1c) disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: GnRH agonist/antagonist — post-prostatectomy
Patients who have already started on post-prostatectomy GnRH agonist/antagonist for <= 180 days prior to registration are eligible
Cannot have received: systemic chemotherapy
Exception: prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)
Cannot have received: radiotherapy
Exception: prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cannot have received: androgen deprivation therapy
Exception: prior to radical prostatectomy
Androgen deprivation therapy (ADT) prior to radical prostatectomy
Cannot have received: androgen receptor signaling inhibitor (abiraterone acetate, enzalutamide, apalutamide, darolutamide)
Exception: unless started <= 180 days and stopped prior to registration, which is allowed
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
Lab requirements
Blood counts
Hemoglobin >= 9.0 g/dL, Platelet count >= 100,000 x 10^9/uL
Kidney function
Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault
Liver function
Total bilirubin <= 1.5 x institutional ULN (Gilbert's syndrome exception: direct bilirubin <= 1.5 x ULN); AST or ALT <= 2.5 x institutional ULN
Hemoglobin >= 9.0 g/dL, Platelet count >= 100,000 x 10^9/uL, Serum potassium >= 3.5 mmol/L, CrCl >= 30 mL/min, Total bilirubin <= 1.5 x ULN (Gilbert's exception), AST or ALT <= 2.5 x ULN, Serum albumin >= 3.0 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify