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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of British Columbia
Study ID
NCT04812366
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide 60mg Tab — DRUG
    4 tablets by mouth once a day for 24 weeks
  • Abiraterone Acetate 250mg — DRUG
    4 tablets by mouth on an empty stomach once a day for 16 weeks
  • Prednisone 5mg Tab — DRUG
    1 tablet by mouth once daily while taking abiraterone acetate
  • Docetaxel — DRUG
    Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks)
  • Niraparib 100mg Oral Capsule — DRUG
    3 capsules by mouth once daily for 16 weeks
  • Atezolizumab — DRUG
    1200mg infusion every 3 weeks for 6 cycles

Study Details

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.

Key Dates

Start date
Sep 21, 2021
Status verified
Aug 2024
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
315 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1a
    LHRHa plus apalutamide.
  • Active Comparator: Group 1b
    LHRHa plus apalutamide plus abiraterone acetate plus prednisone.
  • Active Comparator: Group 2a
    LHRHa plus abiraterone acetate plus prednisone.
  • Active Comparator: Group 2b
    LHRHa plus abiraterone acetate plus prednisone plus docetaxel.
  • Active Comparator: Group 3
    LHRHa plus abiraterone acetate plus prednisone plus niraparib
  • Active Comparator: Group 4
    LHRHa plus apalutamide plus atezolizumab

Primary Outcome Measure

Complete Pathologic Response (pCR) [ Time Frame: 6 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817
Anthony Martinez
[email protected]
916-734-0162
Marc Dall'Era, MD
Mamta Parikh, MD
Brigham & Women's HospitalBostonMassachusetts02115
Daniella Furtado
[email protected]
617-525-8782
Adam Kibel, MD
University of Michigan HealthAnn ArborMichigan48109-5946
Lindsay Sazkaly
[email protected]
734-936-7699
Todd Morgan, MD
U.T. MD Anderson Cancer CenterHoustonTexas77030
askMDAnderson
[email protected]
877-632-6789
Brian Chapin, M.D.
Fred Hutchinson Cancer CenterSeattleWashington98109
Amanda Bard
2066674519
Michael Schweizer, MD

Find similar trials in Sacramento, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California Davis· Sacramento, CABrigham & Women's Hospital· Boston, MAUniversity of Michigan Health· Ann Arbor, MIU.T. MD Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Center· Seattle, WA

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