Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
University of British Columbia
315 participants
Sep 21, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
4 tablets by mouth once a day for 24 weeks
4 tablets by mouth on an empty stomach once a day for 16 weeks
1 tablet by mouth once daily while taking abiraterone acetate
Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks)
3 capsules by mouth once daily for 16 weeks
1200mg infusion every 3 weeks for 6 cycles
Locations(9)
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NCT04812366