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

NCT04812366 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2024-12-16

No results posted yet for this study

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 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

Interventions

DRUG

Apalutamide 60mg Tab

4 tablets by mouth once a day for 24 weeks

DRUG

Abiraterone Acetate 250mg

4 tablets by mouth on an empty stomach once a day for 16 weeks

DRUG

Prednisone 5mg Tab

1 tablet by mouth once daily while taking abiraterone acetate

DRUG

Docetaxel

Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks)

DRUG

Niraparib 100mg Oral Capsule

3 capsules by mouth once daily for 16 weeks

DRUG

Atezolizumab

1200mg infusion every 3 weeks for 6 cycles

Sponsors & Collaborators

  • Janssen Inc.

    collaborator INDUSTRY

  • University Health Network, Toronto

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Martin E Gleave, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2026-04-01
Completion
2026-04-01
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812366 on ClinicalTrials.gov