NCT04812366 · University of British Columbia
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
(GUNS)
What this study 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.
View original scientific description
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.
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
Primary outcome measures
Complete Pathologic Response (pCR)
Time frame: 6 years
Pathological Minimal Residual Disease (pMRD): pathological minimal residual disease (pMRD) is defined as residual tumour 5mm or less.
Pathological Minimal Residual Disease (pMRD)
Time frame: 6 years
Pathological minimal residual disease is defined as residual tumour 5 mm or less.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \- 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 PSM
Where
- Sacramento, California
- Boston, Massachusetts
- Ann Arbor, Michigan
- Houston, Texas
- Seattle, Washington
Collaborators
Janssen Inc., University Health Network, Toronto
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2024 · Source of record for eligibility and locations