Prostate Cancer Genetic Risk Evaluation and Screening Study

ConditionsProstatic Neoplasm Prostate Cancer BRCA2 Mutation BRCA1 Mutation ATM Gene Mutation MMR Mutation Lynch Syndrome Genetic Predisposition to Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age35-74

SponsorMassachusetts General Hospital

About this trial

This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men 35-74 years old

No known diagnosis of prostate cancer

Life expectancy >10 years

Meet cohort A, B, or C criteria

Disqualifiers

Prior diagnosis or treatment of prostate cancer

Inability to undergo prostate MRI

Inability to receive MRI contrast agent

Trial population

Men ages 35-74 years old at high genetic risk for prostate cancer on the basis of a specific germline genetic mutation or a strong family history.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Prostate cancer screening
Diagnostic test
Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate

Treatment groups

400 Participants

are divided into 3 treatment groups

Group A: Cohort A1 intervention

Group B: Cohort B1 intervention

Group C: Cohort C1 intervention

Trial outcomes

Primary outcomes

Diagnosis of prostate cancer

Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer

Time frame

From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first

Secondary outcomes

Positive predictive value of multiparametric MRI for detection of prostate cancer

Positive predictive value of multiparametric prostate MRI for detecting clinically significant prostate cancer in men at high genetic risk for prostate cancer with a positive MRI (PI-RADS score of 3 or higher)

Time frame

From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

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