OncoMatch/Clinical Trials/NCT04812366
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
Is NCT04812366 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for prostate cancer.
Treatment: Apalutamide 60mg Tab · Abiraterone Acetate 250mg · Prednisone 5mg Tab · Docetaxel · Niraparib 100mg Oral Capsule · Atezolizumab — The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response. Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks. Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib. The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage HIGH-RISK LOCALIZED, OLIGOMETASTATIC (< 3) BY PSMA IMAGING ONLY
Excluded: Stage M1 BY CONVENTIONAL IMAGING (CT, BONE SCAN)
High-risk localized prostate cancer as defined by: ... Participants with oligometastatic (< 3) metastases by PSMA imaging only who are deemed candidates for radical prostatectomy are eligible
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: androgen deprivation therapy (LHRHa)
Exception: up to 30 days of LHRHa is allowable prior to treatment
No prior systemic or localized treatment for prostate cancer. Up to 30 days of LHRHa is allowable prior to treatment. Received more than 30 days of LHRHa prior to registration and initiation of LHRHa + APA [excluded].
Cannot have received: androgen deprivation therapy (androgens, estrogens, pregestational agents)
Exception: no prior exposure within 6 months prior to randomization
Receiving concurrent androgens, estrogens, or pregestational agents, or prior exposure to any of these agents within 6 months prior to randomization
Cannot have received: chemotherapy
Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer
Cannot have received: surgery
Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer
Cannot have received: radiation therapy
Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis · Sacramento, California
- Brigham & Women's Hospital · Boston, Massachusetts
- University of Michigan Health · Ann Arbor, Michigan
- U.T. MD Anderson Cancer Center · Houston, Texas
- Fred Hutchinson Cancer Center · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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