OncoMatch/Clinical Trials/NCT04812366
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
Is NCT04812366 recruiting? Yes, currently enrolling (Sep 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 · Tazemetostat Pill · Capivasertib — 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage HIGH-RISK LOCALIZED
High-risk localized prostate cancer as defined by at least one of the following: * Any combination of Gleason Score 4+3=7 and Gleason Score 8 (4+4 or 5+3) in ≥6 systematic cores (with ≥1 core Gleason Score 8 [4+4 or 5+3] included); * Any combination of Gleason Score 4+3 and Gleason Score 8 (4+4 or 5+3) in ≥3 systematic cores and PSA ≥20 ng/mL (with at least 1 core Gleason Score 8 [4+4 or 5+3] included); * Gleason Score ≥9 in at least 1 systematic or targeted core; * At least 2 systematic or targeted cores with Gleason Score ≥8, each with at least 80% involvement; or * Gleason Score 4+3=7 in at least 6 systematic or targeted cores and PSA ≥20 ng/mL
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0 or 1
Demographics
Prior therapy
Cannot have received: androgen deprivation therapy
Exception: up to 12 weeks of LHRHa and bicalutamide is allowable prior to registration
No prior systemic or localized treatment for prostate cancer (exception: up to 12 weeks of luteinizing hormone-releasing hormone agonist or antagonist (LHRHa) and bicalutamide is allowable prior to registration).
Cannot have received: chemotherapy for prostate cancer
Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
Cannot have received: surgery for prostate cancer
Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
Cannot have received: radiation therapy for prostate cancer
Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
Lab requirements
Blood counts
adequate end-organ function
Kidney function
adequate end-organ function
Liver function
adequate end-organ function
Participants must have adequate end-organ function and all laboratory tests must be performed within 8 weeks prior to registration into master protocol (Table 1).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis · Sacramento, California
- Dana-Farber Cancer Institute / Beth Israel Deaconess Medical Center · 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 →Frequently asked questions
Is NCT04812366 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage HIGH-RISK LOCALIZED is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
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 qualifyRelated pages