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Genomic Biomarker-Selected Study for High-Risk Localized Prostate Cancer

This study is for men with high-risk localized prostate cancer. It aims to see if choosing treatments based on the genetic makeup (genomic testing) of your prostate tumor can lead to better results. You would first receive apalutamide and a luteinizing hormone-releasing hormone agonist (LHRHa) for at least 8 weeks while your tumor tissue is genetically tested. Depending on these results, you might then be randomly assigned to continue with LHRHa plus apalutamide, or to also receive abiraterone acetate and prednisone, docetaxel, or niraparib. The study will measure how well these treatments work by looking at the complete disappearance of cancer (complete pathologic response) or very little remaining cancer (pathological minimal residual disease) after 6 years. The study is currently unclear on its status and plans to enroll 315 participants.

Study design
This is a multi-center, adaptive, multi-arm Phase 2 study. It involves an initial treatment period followed by assignment to different treatment groups based on genomic profiling, with a planned enrollment of 315 participants.
What's involved
You would receive apalutamide and an LHRHa for at least 8 weeks, with some continuing for an additional 16 weeks. Depending on your genomic profile, you might then be randomized to receive additional medications like abiraterone acetate, prednisone, docetaxel (infusion every 3 weeks for 6 cycles), or niraparib.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes like complete pathologic response and pathological minimal residual disease after 6 years, indicating a long-term follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04812366

Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of British Columbia
~315 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Apalutamide 60mg TabAbiraterone Acetate 250mgPrednisone 5mg TabDocetaxelNiraparib 100mg Oral CapsuleAtezolizumab

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Pathologic Response (pCR)
Measured over 6 years
+1 more outcome measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

9 sites across 7 states
Ontario3
California1
Massachusetts1
Michigan1
Texas1
Washington1
British Columbia1

Study leadership

  • Martin E Gleave, MD · STUDY_CHAIR · University of British Columbia

Who to contact

Martin E Gleave, MD
[email protected]
604-875-5006
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 iv. Participants must provide consent blood collection and evaluation of diagnostic prostate tissue for genetic testing at registration and prior to assignment by a central reference laboratory.

Exclusion

Active infection or chronic liver disease requiring systemic therapy;
Active or known human immunodeficiency virus (HIV) with detectable viral load;
Participants with uncontrolled hypertension or diabetes.
Uncontrolled or recent clinically significant cardiac disease, including history of any of the following within 12 months prior to screening:
Severe or unstable angina, symptomatic pericarditis, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease, coronary artery bypass grafting, coronary angioplasty, stenting, or myocardial infarction; uncomplicated deep vein thrombosis is not considered exclusionary).
History of any cardiac arrhythmias that preclude prostatectomy or treatment with study drugs, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality.

What this trial measures

  • Complete Pathologic Response (pCR)6 years

    Pathological Minimal Residual Disease (pMRD): pathological minimal residual disease (pMRD) is defined as residual tumour 5mm or less.

  • Pathological Minimal Residual Disease (pMRD)6 years

    Pathological minimal residual disease is defined as residual tumour 5 mm or less.