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Search / Trial NCT06398639

Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer

Launched by ADAM S. KIBEL, MD · Apr 30, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Polygenic Risk Score Prostate Cancer Prostate Cancer Screening Multiparametric Mri

ClinConnect Summary

This clinical trial is studying a new way to screen for prostate cancer using genetic information and advanced imaging techniques. The goal is to see if combining genetic data with a type of MRI, called multiparametric MRI (mpMRI), can help identify men who are at higher risk for serious prostate cancer. Researchers want to find out the best age for men to start getting these screenings and whether using modern computer techniques can improve the accuracy of detecting significant cancer cases.

To participate, men aged 40 to 69 who have never had prostate cancer and meet certain health criteria can join the trial. Participants will undergo a blood test to check for prostate-specific antigen (PSA), have an mpMRI scan, and receive genetic testing to assess their risk level for prostate cancer. Based on these results, they will have follow-up evaluations. Overall, this trial aims to improve early detection and treatment of prostate cancer to help save lives.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About Adam S. Kibel, Md

Dr. Adam S. Kibel, MD, is a distinguished clinical trial sponsor with extensive expertise in oncology and urologic surgery. He is renowned for his commitment to advancing cancer research, particularly in the areas of prostate and bladder cancers. Dr. Kibel leads innovative clinical trials aimed at evaluating novel therapeutic strategies and improving patient outcomes. His dedication to integrating cutting-edge scientific methodologies with compassionate care underscores his role as a pivotal figure in the development of effective treatment options within the oncology community.

Locations

Washington, District Of Columbia, United States

Bethesda, Maryland, United States

Bethesda, Maryland, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Adam S Kibel, MD, MHCM

Study Chair

Brigham and Women's Hospital

Peter Pinto, MD

Study Chair

National Cancer Institute (NCI)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported