RecruitingPhase IIMale onlyEN originalProstate cancer

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Mężczyźni w wieku 18 lat i starsi.
  • Potwierdzony rak prostaty (gruczołak), bez cech raka drobnokomórkowego.
  • Rak prostaty zlokalizowany, ale o wysokim ryzyku nawrotu (szczegółowe kryteria dotyczące wyników badań)
  • Pacjent zgadza się na pobranie krwi i analizę tkanki guza pod kątem genetycznym.
  • Brak wcześniejszego leczenia systemowego lub miejscowego raka prostaty (możliwe wyjątki, np. krótkie leczenie hormonalne przed badaniem).
  • Ogólny stan zdrowia pozwalający na udział w badaniu (dokładnie opisany w protokole badania).

✗ Disqualifies

  • Pacjenci, u których tkanka guza jest niemożliwa do analizy genetycznej (zostaną objęci innym etapem leczenia w ramach badania).
  • Pacjenci z przerzutami raka prostaty.
  • Pacjenci, u których nie ma wystarczających wyników badań laboratoryjnych.
  • Pacjenci nie wyrażający zgody na udział w badaniu.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 14, 2026
Sex
Male only

Therapies / drugs in trial

Locations (9)

University of California Davis

Sacramento, United States

Dana-Farber Cancer Institute / Beth Israel Deaconess Medical Center

Boston, United States

University of Michigan Health

Ann Arbor, United States

U.T. MD Anderson Cancer Center

Houston, United States

Fred Hutchinson Cancer Center

Seattle, United States

Vancouver Prostate Centre

Vancouver, Canada

London Health Sciences Centre

London, Canada

Ottawa Hospital Research Institute (OHRI)

Ottawa, Canada

University Health Network

Toronto, Canada

Trial contact

Martin E Gleave, MD

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.

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