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Hormone Therapy

Genomic Biomarker-Selected Therapy for Prostate Cancer (GUNS Trial)

Phase 2
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 (Appendix II) and a life expectancy of ≥ 3 years
Males ≥ 18 years of age
Must not have
Stage T4 prostate cancer by clinical examination or radiologic evaluation
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a therapy based on the genomic testing of prostate tumour tissue will improve clinical response. Participants will be treated with LHRHa plus APA for 8 weeks while genome sequence characterization is done. Those with unevaluable tissue will remain on LHRHa plus APA for 16 weeks. Those with evaluable tissue will be assigned to one of three sub-studies and randomized to a specific treatment arm. The study will evaluate response rate and outcomes after radical prostatectomy.

Who is the study for?
Men over 18 with high-risk localized prostate cancer, no prior treatments for it, and willing to undergo genetic testing. They must have a life expectancy of at least 3 years and be in good health otherwise. Men with severe diseases, allergies to study drugs, or who can't take oral meds are excluded.
What is being tested?
The trial tests if targeted therapy based on genomic profiling improves response in men with prostate cancer. After initial treatment with hormone therapy plus apalutamide, participants may receive additional drugs like abiraterone acetate and prednisone, docetaxel or niraparib depending on their tumor's genetics.
What are the potential side effects?
Possible side effects include hormonal changes due to LHRHa and APA, immune reactions from Atezolizumab, nerve issues from Niraparib, liver problems from Abiraterone Acetate & Prednisone combo; fatigue and allergic reactions are also possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly active and my doctor expects me to live 3 more years or longer.
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I am a man aged 18 or older.
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My prostate cancer was confirmed without small cell features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer is advanced (Stage T4) as confirmed by tests.
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I do not have serious illnesses that could increase my risk in the study.
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I have had treatments like hormone therapy, chemotherapy, surgery, or radiation for prostate cancer.
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I can swallow pills and don't have major stomach or bowel issues affecting drug absorption.
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I have been on LHRHa treatment for over 30 days before starting LHRHa + APA.
Select...
My testosterone levels are significantly lower than normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Pathologic Response (pCR)
Pathological Minimal Residual Disease (pMRD)
Secondary study objectives
Generic Quality of Life (QoL)
Pain
Malignant neoplasm of prostate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Active Control
Group I: Group 1bActive Control3 Interventions
LHRHa plus apalutamide plus abiraterone acetate plus prednisone.
Group II: Group 1aActive Control1 Intervention
LHRHa plus apalutamide.
Group III: Group 2aActive Control2 Interventions
LHRHa plus abiraterone acetate plus prednisone.
Group IV: Group 2bActive Control3 Interventions
LHRHa plus abiraterone acetate plus prednisone plus docetaxel.
Group V: Group 3Active Control3 Interventions
LHRHa plus abiraterone acetate plus prednisone plus niraparib
Group VI: Group 4Active Control2 Interventions
LHRHa plus apalutamide plus atezolizumab

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,146 Total Patients Enrolled
9 Trials studying Prostate Cancer
2,448 Patients Enrolled for Prostate Cancer
Janssen Inc.Industry Sponsor
23 Previous Clinical Trials
7,766 Total Patients Enrolled
University Health Network, TorontoOTHER
1,521 Previous Clinical Trials
502,989 Total Patients Enrolled
65 Trials studying Prostate Cancer
15,277 Patients Enrolled for Prostate Cancer

Media Library

Apalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04812366 — Phase 2
Prostate Cancer Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT04812366 — Phase 2
Apalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04812366 — Phase 2
~93 spots leftby Apr 2026
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