Status:
RECRUITING
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Janssen Inc.
University Health Network, Toronto
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a multi-centre adaptive multi-arm phase II study. Participants are treated with an induction period of at least 8 weeks of LHRH agonist/antagonist (LHRHa) plus apalutamide (APA) while genome s...
Eligibility Criteria
Inclusion
- \- I. Males ≥ 18 years of age
- II. Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell differentiation at the time of initial diagnosis
- III. High-risk localized prostate cancer as defined by:
- PSA (prostate specific antigen) \>20, any GS or \>8 or
- Gleason pattern 4 in 6 or more systematic cores (pattern 4 must be dominant, ≥50% average across 6 or more systematic cores) or
- ≥ 50% Gleason pattern 4 in 3 or more systematic or Magnetic Resonance Imaging (MRI)-targeted cores and PSA ≥ 20 (may include G4+3 or G4+4 but pattern 4 must be dominant, ≥50% average across 3 or more systematic cores) or
- ≥25% Gleason pattern 5 in 3 or more systematic or MRI-targeted cores (may include G4+5, or G3+5, but pattern 5 must be ≥25% average across 3 or more systematic cores).
- Gleason \> 8 or greater on minimum of one core either targeted or systematic biopsy and PSA \>20
- Participants with oligometastatic (\< 3) metastases by PSMA (Prostate-Specific Membrane Antigen) imaging only who are deemed candidates for radical prostatectomy are eligible
- IV. Participants must consent to genetic testing at registration and prior to assignment by a central reference laboratory
- V. No prior systemic or localized treatment for prostate cancer. Up to 30 days of LHRHa is allowable prior to treatment.
- VI. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 (Appendix II) and a life expectancy of ≥ 3 years
- VII. Participants must have adequate end-organ function and all laboratory tests must be performed within 4 weeks prior to registration into master protocol.
- VIII. Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate.
Exclusion
- \- I. Received more than 30 days of LHRHa prior to registration and initiation of LHRHa + APA
- II. Stage T4 prostate cancer by clinical examination or radiologic evaluation
- III. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution
- IV. Participants with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the participant to be managed according to the protocol. This includes but is not limited to:
- Active infection or chronic liver disease requiring systemic therapy;
- Active or known human immunodeficiency virus (HIV) with detectable viral load;
- Uncontrolled or recent clinically significant cardiac disease, including: angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months; history of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy; history of any cardiac arrhythmias, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months;
- Participants with uncontrolled hypertension
- V. Participants who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- VI. Participants with a history of hypersensitivity to any of the study drugs or any excipient
- VII. Participants with a history of non-compliance to medical regimen
- VIII. Severe concurrent disease, infection, or co-morbidity that, in the judgement of the Investigator, would make the participant inappropriate for enrollment or prostatectomy
- IX. Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer
- X. Receiving concurrent androgens, estrogens, or pregestational agents, or prior exposure to any of these agents within 6 months prior to randomization
- XI. M1 by conventional imaging (CT, bone scan)
Key Trial Info
Start Date :
September 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04812366
Start Date
September 21 2021
End Date
April 1 2026
Last Update
December 16 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Davis
Sacramento, California, United States, 95817
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
University of Michigan Health
Ann Arbor, Michigan, United States, 48109-5946
4
U.T. MD Anderson Cancer Center
Houston, Texas, United States, 77030