Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
Status:
Recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
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.