Prostate CancerPRSNCT06398639
Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
A study testing Polygenic Risk Score (PRS) in people with Prostate Cancer and Polygenic Risk Score, run by Adam S. Kibel, MD at 5 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer. Read more about this study
- Who is it for?
- Ages 40 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Polygenic Risk Score
- What is being tested?
- Polygenic Risk Score (PRS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 May 2024to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- They must have the ability to understand and the willingness to sign a written information consent document.
- Estimated life expectancy of greater than 10 years.
- No history of prostate cancer.
- Participants must be between 40-69 years of age. This is the age at which screening for prostate cancer is recommended. This is due to younger patients not being at risk for the disease and older patients not benefiting from diagnosis.
- No biopsy for prostate cancer within the past 5 years.
- No prostate MRI within the past 5 years.
Who cannot join
- Unwillingness to sign the informed consent form.
- Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder.
- Uncontrolled intercurrent illness including, but not limited to, 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.
- Unable to undergo an MRI.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
National Cancer Institute
Bethesda, Maryland, 20814
Peter A Pinto, MD, 204-858-7200, pintop@mail.nih.gov
Ismail B Turkbey, MD
- Not yet recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Gregory T Chesnut, MD, 301-319-2900, gregory.chesnut@usuhs.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Keyan Salari, MD, PhD, 857-238-3838, ksalari@mgh.harvard.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02155
Adam S Kibel, MD, MHCM, 617-525-7697, akibel@bwh.harvard.edu
- Not yet recruiting
Howard University Hospital
Washington D.C., District of Columbia, 20060
Pamela Coleman, MD
Tamaro S Hudson, PhD, MPH
About this study
The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer.
The main questions it aims to answer are:
Read more
- If genetic data related to prostate cancer used with MRI can identify higher-grade, potentially fatal prostate cancer
- What age a MRI is useful clinically for prostate cancer screening
- If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers
Participants will:
- Get a prostate specific antigen (PSA) blood test
- Get an mpMRI
- Get the results of their genetic data to determine if they are considered high-, intermediate-, or low-risk for prostate cancer based on the trials genetic testing
- Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI
Read the detailed description
Background:
- Prostate cancer is the most commonly diagnosed cancer among men in the United States
- Prostate cancer screening using the marker prostate-specific antigen (PSA) is controversial
- PSA based screening is less effective, at least in part, because it rests on screening the entire population
- Polygenic risk scores stratify men based on their prostate cancer genetic predisposition and may improve population level screening programs by focusing on men with higher risk of disease and sparing low risk men
- It is critical that studies aiming to translate the development of an early-detection strategy are conducted within a diverse patient population to address prostate cancer mortality disparities
Study Design:
- Plan to accrue 1,500 participants from both established biobanks and primary care offices
- Participants will get an initial PSA screening blood test and an mpMRI
- Participants will have their polygenic risk score determined from genome-wide association study (GWAS) data
- Participant follow-up will be determined by PRS results, as well as if there are abnormal findings on their PSA screening and/or mpMRI
Objectives:
- To evaluate a screening algorithm to detect clinically relevant prostate cancer (Gleason score ≥7) using genetic data (PRS) to determine risk of cancer and mpMRI to identify men with higher grade cancer
- To determine optimal age to begin screening using PRS and mpMRI
- To determine if rare variants in DNA repair enzymes could help refine screening
- To determine if deep learning methods applied to mpMRI and informed by genetic risk can more accurately predict significant cancers
Prostate cancer screening using prostate specific antigen (PSA) is controversial. On the one hand, there is a reduction in prostate cancer mortality associated with screening. On the other, there is clear evidence that widespread and indiscriminate PSA based screening has led to over diagnosis and over treatment of prostate cancer. In part this is due to indiscriminate screening of all men, not just those at risk. Development and implementation of a screening strategy specifically targeting men at risk for potentially harmful prostate cancer, while sparing low risk men the burdens of screening, is urgently needed.
The investigators believe that integration of genetic testing and multiparametric MRI (mpMRI) will dramatically improve screening. Polygenic risk scores (PRS) have been developed to determine an individual's risk of prostate cancer and attempts have been made to create risk scores for clinically relevant disease. mpMRI has been established as an aid in differentiating clinically relevant from indolent prostate cancer.
Our scientific premise is that an integrated approach which leverages the strengths of both genetics and mpMRI will do more than simply risk stratify men into those at risk for and not at risk for prostate cancer; the investigators will stratify a population of men into those with and those without clinically relevant prostate cancer. The investigators hypothesize that genetic testing to first identify patients at risk of prostate cancer followed by mpMRI to determine who likely has clinically relevant disease represents an optimal strategy.
This study will determine if a polygenic risk score can be used in conjunction with mpMRI to identify Gleason score ≥7 cancer.
- Conditions
- Prostate Cancer, Polygenic Risk Score
- Being tested
- Polygenic Risk Score (PRS)
- Keywords
- Polygenic Risk Score, Prostate Cancer, Prostate Cancer Screening, Multiparametric MRI
- Medical subject headings
- Prostatic Neoplasms, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygenic Risk Score (PRS)Other
Participants will be put into PRS cohorts based on their genetic data.
All participants enrolled into the study will receive a PSA screening test and an mpMRI, regardless of their polygenic risk score.
| Study group | Role | What they receive |
|---|---|---|
| Low Risk Cohort | Other | Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk. Receives: Other: Polygenic Risk Score (PRS) |
| Intermediate Risk Cohort | Other | Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk. Receives: Other: Polygenic Risk Score (PRS) |
| High Risk Cohort | Other | Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk. Receives: Other: Polygenic Risk Score (PRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Ratio - Three Age Groups
The ratio between men with high PRS and intermediate PRS in each of the three age groups (40-54, 55-64, 65-69) regardless of their ethnicity.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (2)
Risk Ratio - Six Age Groups
The ratio between men with high PRS and intermediate PRS in each of the six age groups (40-44, 45-49, 50-54, 55-59, 60-64, 65-69) regardless of their ethnicity.
Measured: Through study completion, an average of 1 year.
Rare Variants
Examine the extent to which the addition of rare variants to the PRS involves risk prediction. The weighting procedure will be implemented to account for oversampling of high risk cases.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start7 May 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adam S. Kibel, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Adam S. Kibel, MD, Brigham and Women's Hospital
- Investigators
- Adam S Kibel, MD, MHCM, Study chair, Brigham and Women's HospitalPeter Pinto, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398639
- Sponsor's protocol ID
- 23-564
- Other IDs
- U01CA268810
- Acronym
- PRS
- Status last verified
- Nov 2025
- First submitted
- 28 Apr 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06398639
- Acronym / sponsor ID
- PRS / 23-564
- Conditions
- Prostate Cancer, Polygenic Risk Score
- Keywords
- Polygenic Risk Score, Prostate Cancer, Prostate Cancer Screening, Multiparametric MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Adam S. Kibel, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer.
The main questions it aims to answer are:
- If genetic data related to prostate cancer used with MRI can identify higher-grade, potentially fatal prostate cancer
- What age a MRI is useful clinically for prostate cancer screening
- If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers
Participants will:
- Get a prostate specific antigen (PSA) blood test
- Get an mpMRI
- Get the results of their genetic data to determine if they are considered high-, intermediate-, or low-risk for prostate cancer based on the trials genetic testing
- Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI
Detailed description
Background:
- Prostate cancer is the most commonly diagnosed cancer among men in the United States
- Prostate cancer screening using the marker prostate-specific antigen (PSA) is controversial
- PSA based screening is less effective, at least in part, because it rests on screening the entire population
- Polygenic risk scores stratify men based on their prostate cancer genetic predisposition and may improve population level screening programs by focusing on men with higher risk of disease and sparing low risk men
- It is critical that studies aiming to translate the development of an early-detection strategy are conducted within a diverse patient population to address prostate cancer mortality disparities
Study Design:
- Plan to accrue 1,500 participants from both established biobanks and primary care offices
- Participants will get an initial PSA screening blood test and an mpMRI
- Participants will have their polygenic risk score determined from genome-wide association study (GWAS) data
- Participant follow-up will be determined by PRS results, as well as if there are abnormal findings on their PSA screening and/or mpMRI
Objectives:
- To evaluate a screening algorithm to detect clinically relevant prostate cancer (Gleason score ≥7) using genetic data (PRS) to determine risk of cancer and mpMRI to identify men with higher grade cancer
- To determine optimal age to begin screening using PRS and mpMRI
- To determine if rare variants in DNA repair enzymes could help refine screening
- To determine if deep learning methods applied to mpMRI and informed by genetic risk can more accurately predict significant cancers
Prostate cancer screening using prostate specific antigen (PSA) is controversial. On the one hand, there is a reduction in prostate cancer mortality associated with screening. On the other, there is clear evidence that widespread and indiscriminate PSA based screening has led to over diagnosis and over treatment of prostate cancer. In part this is due to indiscriminate screening of all men, not just those at risk. Development and implementation of a screening strategy specifically targeting men at risk for potentially harmful prostate cancer, while sparing low risk men the burdens of screening, is urgently needed.
The investigators believe that integration of genetic testing and multiparametric MRI (mpMRI) will dramatically improve screening. Polygenic risk scores (PRS) have been developed to determine an individual's risk of prostate cancer and attempts have been made to create risk scores for clinically relevant disease. mpMRI has been established as an aid in differentiating clinically relevant from indolent prostate cancer.
Our scientific premise is that an integrated approach which leverages the strengths of both genetics and mpMRI will do more than simply risk stratify men into those at risk for and not at risk for prostate cancer; the investigators will stratify a population of men into those with and those without clinically relevant prostate cancer. The investigators hypothesize that genetic testing to first identify patients at risk of prostate cancer followed by mpMRI to determine who likely has clinically relevant disease represents an optimal strategy.
This study will determine if a polygenic risk score can be used in conjunction with mpMRI to identify Gleason score ≥7 cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Risk Cohort | Other | Other: Polygenic Risk Score (PRS)Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk. |
| Intermediate Risk Cohort | Other | Other: Polygenic Risk Score (PRS)Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk. |
| High Risk Cohort | Other | Other: Polygenic Risk Score (PRS)Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- They must have the ability to understand and the willingness to sign a written information consent document.
- Estimated life expectancy of greater than 10 years.
- No history of prostate cancer.
- Participants must be between 40-69 years of age. This is the age at which screening for prostate cancer is recommended. This is due to younger patients not being at risk for the disease and older patients not benefiting from diagnosis.
- No biopsy for prostate cancer within the past 5 years.
Key exclusion criteria (4 listed)
- Unwillingness to sign the informed consent form.
- Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder.
- Uncontrolled intercurrent illness including, but not limited to, 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.
- Unable to undergo an MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygenic Risk Score (PRS)Participants will be put into PRS cohorts based on their genetic data. All participants enrolled into the study will receive a PSA screening test and an mpMRI, regardless of their polygenic risk score. | Other | High Risk Cohort, Intermediate Risk Cohort, Low Risk Cohort |
Primary outcome
Risk Ratio - Three Age Groups
Time frame: Through study completion, an average of 1 year.
The ratio between men with high PRS and intermediate PRS in each of the three age groups (40-54, 55-64, 65-69) regardless of their ethnicity.
2 secondary outcomes
Risk Ratio - Six Age Groups
Time frame: Through study completion, an average of 1 year.
Rare Variants
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam S Kibel, MD, MHCM study chair
Brigham and Women's Hospital
Peter Pinto, MD study chair
National Cancer Institute (NCI)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygenic Risk Score (PRS) in people with Prostate Cancer and Polygenic Risk Score, run by Adam S. Kibel, MD at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam S Kibel, MD, MHCM ((617) 525-7697, akibel@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Ratio - Three Age Groups (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025; AzTrials last refreshed its copy on 31 Oct 2026.