Clinical trial for Prostate Cancer
Official title Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
ClinicalTrials.gov ID: NCT04812366
What this study is testing
What is Apalutamide 60mg Tablet?
An investigational oral medication being studied for prostate cancer. It is designed to block androgen receptors in prostate cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether choosing therapy based on a tumor’s DNA test leads to better outcomes after surgery.
- Who it's for
- Men with high‑risk, localized prostate cancer who can give a biopsy sample for DNA testing.
- What's involved
- Participants receive 8 weeks of a hormone‑suppressing drug plus apalutamide while their tumor DNA is analyzed. If the DNA test works, they are randomly assigned to one of several treatment options that add either abiraterone, docetaxel, or niraparib to the standard drugs. If the DNA test fails, they stay on the standard drugs for 16 more weeks.
- Time commitment
- The study lasts about 8 to 24 weeks of medication, followed by a prostate surgery and follow‑up visits to measure treatment response.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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
- Gleason Score 4+3=7 in at least 6 systematic or targeted cores and PSA ≥20 ng/mL iv.
You likely can't join if
- 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...
- History of any cardiac arrhythmias that preclude prostatectomy or treatment with study drugs, e.g.
The study team makes the final eligibility decision.
Where it is enrolling
- Sacramento, California, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sacramento, California, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Houston, Texas, United States; Seattle, Washington, United States; Vancouver, British Columbia, Canada and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.