Actively Recruiting
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
Led by University of British Columbia · Updated on 2024-12-16
315
Participants Needed
9
Research Sites
236 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
J
Janssen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Histologically confirmed adenocarcinoma of the prostate without small cell differentiation
- High-risk localized prostate cancer defined by PSA >20, certain Gleason pattern thresholds, or limited oligometastatic disease by PSMA imaging
- Consent to genetic testing of tumor tissue
- No prior systemic or localized treatment for prostate cancer except up to 30 days of LHRHa
- ECOG performance status 0 or 1 and life expectancy of at least 3 years
- Adequate organ function with laboratory tests within 4 weeks prior to registration
- Signed informed consent according to local regulations
You will not qualify if you...
- More than 30 days of LHRHa treatment before registration
- Stage T4 prostate cancer by clinical or radiologic evaluation
- Severe androgen deficiency with serum testosterone significantly below normal
- Serious illnesses or conditions posing safety risks or preventing protocol management, including active infection, chronic liver disease, detectable HIV viral load, recent significant cardiac disease, uncontrolled hypertension
- Inability to swallow oral medication or gastrointestinal conditions affecting drug absorption
- History of allergy to study drugs or excipients
- History of non-compliance with medical regimens
- Severe concurrent disease or co-morbidity making participation inappropriate
- Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer
- Current or recent use of androgens, estrogens, or pregestational agents within 6 months
- Distant metastatic disease (M1) by conventional imaging
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
University of Michigan Health
Ann Arbor, Michigan, United States, 48109-5946
Actively Recruiting
4
U.T. MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
6
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
7
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
8
Ottawa Hospital Research Institute (OHRI)
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
9
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
M
Martin E Gleave, MD
CONTACT
T
Tiiu Sildva, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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