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
Qualifiers
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
Treatments tested in this trial
- Polygenic Risk Score (PRS)
Treatment groups
1,500 Participants
are divided into 3 treatment groupsSponsors and collaborators
Adam S. Kibel, MD
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov