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

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 geno

Trial Details

NCT ID
NCT04812366
Phase
PHASE2
Sponsor
University of British Columbia
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Apalutamide 60mg Tab
  • Abiraterone Acetate 250mg
  • Prednisone 5mg Tab
  • Docetaxel
  • Niraparib 100mg Oral Capsule
  • Atezolizumab
Locations (sample)
  • Sacramento, California, United States|38.58157,-121.4944
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • Houston, Texas, United States|29.76328,-95.36327
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • i. Males ≥ 18 years of age. ii. Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell differentiation a…
  • iii. High-risk localized prostate cancer as defined by at least one of the following:
  • Any combination of Gleason Score 4+3=7 and Gleason Score 8 (4+4 or 5+3) in ≥6 systematic cores (with ≥1 core Gleason Score 8 \[4+4 or 5+3\] included);
  • Any combination of Gleason Score 4+3 and Gleason Score 8 (4+4 or 5+3) in ≥3 systematic cores and PSA ≥20 ng/mL (with at least 1 core Gleason Score …

For full eligibility, visit ClinicalTrials.gov.

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