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NCT04812366 · ClinicalTrials.gov registry record · Phase 2
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by University of British Columbia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 315
- Enrollment target
- 9
- Study locations
NCT04812366: Recruiting Phase 2 study of Prostate Cancer, sponsored by University of British Columbia.
NCT04812366 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by University of British Columbia. The registered enrollment target is 315 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (48% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04812366, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by University of British Columbia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 315 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Apalutamide 60mg Tab
- DRUG Abiraterone Acetate 250mg
- DRUG Prednisone 5mg Tab
- DRUG Niraparib 100mg Oral Capsule
Study Locations (9)
Ontario
- London Health Sciences Centre - London
- Ottawa Hospital Research Institute (OHRI) - Ottawa
- University Health Network - Toronto
California
- University of California Davis - Sacramento
Massachusetts
- Brigham & Women's Hospital - Boston
Michigan
- University of Michigan Health - Ann Arbor
Texas
- U.T. MD Anderson Cancer Center - Houston
Washington
- Fred Hutchinson Cancer Center - Seattle
British Columbia
- Vancouver Prostate Centre - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04812366
The ClinicalTrials.gov registry entry for NCT04812366 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (48% lower). The listed sponsor is University of British Columbia, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT04812366 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Ontario, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04812366 about?
NCT04812366 is a clinical study titled "Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer". 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 (A...
What is the current status of trial NCT04812366?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 315 participants. The study started on 2021-09-21. Estimated completion is 2026-04-01.
What conditions does trial NCT04812366 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04812366?
The interventions under investigation include: Docetaxel (DRUG), Apalutamide 60mg Tab (DRUG), Abiraterone Acetate 250mg (DRUG), Prednisone 5mg Tab (DRUG), Niraparib 100mg Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT04812366?
This trial is sponsored by University of British Columbia, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04812366 being conducted?
This trial has 9 study locations across California, Massachusetts, Michigan, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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