Health Trials

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

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of British Columbia

About this 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.

Eligibility criteria

Qualifiers

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 8 [4+4 or 5+3] included);

Gleason Score ≥9 in at least 1 systematic or targeted core;

At least 2 systematic or targeted cores with Gleason Score ≥8, each with at least 80% involvement"; or

Disqualifiers

Active infection or chronic liver disease requiring systemic therapy;

Active or known human immunodeficiency virus (HIV) with detectable viral load;

Participants with uncontrolled hypertension or diabetes.

Severe or unstable angina, symptomatic pericarditis, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease, coronary artery bypass grafting, coronary angioplasty, stenting, or myocardial infarction; uncomplicated deep vein thrombosis is not considered exclusionary).

Trial design

Treatments tested in this trial

  • Apalutamide 60mg Tab
  • Abiraterone Acetate 250mg
  • Prednisone 5mg Tab
  • Docetaxel
  • Niraparib 100mg Oral Capsule
  • Atezolizumab
  • Tazemetostat Pill
  • Capivasertib

Treatment groups

315 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of British Columbia

Lead sponsor

Janssen Inc.

Collaborator

University Health Network, Toronto

Collaborator

Source ClinicalTrials.gov