Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-69
SponsorAdam S. Kibel, MD
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Polygenic Risk Score (PRS)
Other interventionParticipants 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.
Treatment groups
1,500 Participants
are divided into 3 treatment groupsGroup A: Low Risk CohortOther 1 intervention
Group B: Intermediate Risk CohortOther 1 intervention
Group C: High Risk CohortOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 year.Secondary outcomes
1
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.
Time frame
Through study completion, an average of 1 year.2
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.
Time frame
Through study completion, an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Adam S. Kibel, MD
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov