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Genetic Testing

Genetic Screening and MRI for Prostate Cancer (PRS Trial)

N/A
Recruiting
Research Sponsored by Adam S. Kibel, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 40-69 years
No biopsy for prostate cancer within the past 5 years
Must not have
Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery
Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a screening method for detecting aggressive prostate cancer. It combines genetic data to assess cancer risk with MRI scans to identify men with high-grade cancer. The trial seeks to determine if this

Who is the study for?
This trial is for men being screened for prostate cancer. It's especially focused on those who might have a higher genetic risk, determined by their Polygenic Risk Score (PRS). Participants will undergo an mpMRI scan and a PSA blood test to assess their cancer risk and need regular follow-ups based on these results.
What is being tested?
The study is testing if combining genetic data with mpMRI can better identify serious prostate cancers that could be life-threatening. It also explores the best age for MRI screening and if deep learning improves predictions when genetic risks are known.
What are the potential side effects?
Since this trial involves non-invasive procedures like MRI scans and blood tests, side effects are minimal but may include discomfort during the MRI or minor bruising from blood draws.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 69 years old.
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I have not had a prostate biopsy in the last 5 years.
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I have never had prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have any severe illnesses that would make surgery risky.
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I cannot have a biopsy due to bleeding or clotting issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Risk Ratio - Three Age Groups
Secondary study objectives
Rare Variants
Risk Ratio - Six Age Groups

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Low Risk CohortExperimental Treatment1 Intervention
Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.
Group II: Intermediate Risk CohortExperimental Treatment1 Intervention
Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.
Group III: High Risk CohortExperimental Treatment1 Intervention
Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.

Find a Location

Who is running the clinical trial?

Adam S. Kibel, MDLead Sponsor
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,012,965 Total Patients Enrolled
515 Trials studying Prostate Cancer
331,460 Patients Enrolled for Prostate Cancer
Adam S Kibel, MD, MHCMStudy ChairBrigham and Women's Hospital
~1000 spots leftby Apr 2028
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