Study #2022-0748
Genomic biomarker-selected umbrella neoadjuvant study (GUNS) For high risk localized prostate cancer
MD Anderson Study Status
Enrolling
Treatment Agent
Apalutamide 60mg Tab, Abiraterone Acetate 250mg, Prednisone 5mg Tab, Docetaxel, Niraparib 100mg Oral Capsule, Atezolizumab
Description
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.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Prostate Cancer
Study phase:
Phase II
Physician name:
Brian Chapin
Department:
Urology
For general questions about clinical trials:
1-855-939-4993
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