Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy

NCT05872503 | Terminated

• 2 other identifiers: 10001567001567-C
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Prostate cancer (PCa) is one of the most common cancers in American men; it is a leading cause of death. Men of African ancestry have a higher rate of prostate cancer, and a higher likelihood of death, compared to men of European ancestry. The reasons for these higher rates are not known; they may include genetic and environmental factors. Better screening methods are needed. Objective: To test an imaging technology called multiparametric magnetic resonance imaging (mpMRI) for detecting prostate cancer in men of African ancestry. Eligibility: Men of African ancestry aged 35 years or older with prostate cancer and/or a strong family history of prostate cancer. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Participants will have an mpMRI. They will lie on a narrow bed that slides into a large cylinder. They will lie still for about 45 minutes. They will hear loud noises during the scan; they may wear earplugs or headphones to muffle the sound. Some participants may have a dye injected into a vein. If the scan indicates participants risk of prostate cancer is medium or high, they will have a biopsy: The area will be numbed, and samples of tissue will be removed from the prostate. The biopsy will be done within 6 months. If the scan indicates participants risk of prostate cancer is low, they will not have a biopsy. All participants will be followed for 5 years. They and/or their local doctors will be contacted once a year for follow-up. Additional mpMRIs may be recommended.

Conditions

Prostate Specific Antigens; Positive Digital Rectal Examination; Strong Family History of Prostate Cancer; Prostatic Neoplasms

Keywords

Health Disparity; Multiparametric MRI; MRI-Guided Biopsy; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Cancer detection rate

  To compare results of mpMRI and mpMRI guided biopsy in diagnosing clinically significant prostate cancer between men of African Ancestry (AA) from hospitals providing medical care for communities of color (e.g., Howard University Hospital, Washington Hospital Center) with the population of self-referred participants seen at NIH who are mostly Caucasian.

  mpMRI performed at baseline visit 1 and mpMRI guided biopsy performed within 6 months after that in participants with PI-RADS score >=3.

Secondary Outcomes (5)

• Provide a summary of the report to local health insurance companies

  End of study

• Sensitivity and Area under the curve (AUC)

  Study duration

• Prostate cancer status and overall survival in mid-term (5 years) follow up

  5 years

• Genomic sequencing findings

  Baseline visit 1 and visit 2.

• Polygenic risk score

  Study duration

Study Arms (1)

Cohort 1

Participants of African Ancestry with elevated serum prostate specific antigen of (Bullet)3ng/ml or positive digital rectal examination or strong family history.

Eligibility Criteria

• Age: 35 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is expected that participants for this single site study will be enrolled through referral from primary care clinics of local hospitals serving communities of color.

You may qualify if:

• Age \>35 years.
• Men self-identified as being of African Ancestry.
• Elevated serum prostate specific antigen of \>=3ng/ml and/or positive digital rectal examination and/or strong family history of prostate cancer (at least 1 first or second degree male relative).
• ECOG performance status \<=2.
• Ability of participant to understand and the willingness to sign a written informed consent document.
• Must be co-enrolled in protocols 16-C-0010 and/or 18-C-0017.

You may not qualify if:

• Prior prostate biopsy.
• Prior radiotherapy or surgery for prostate cancer.
• Prior or ongoing hormonal therapy or chemotherapy (e.g., docetaxel) for prostate cancer.
• Participants unwilling or unable to undergo MRI, including participants with contraindications to MRI.
• Participants unwilling or unable to undergo biopsy, including participants with contraindications to biopsy.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ismail B Turkbey, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 24, 2023
• Study Start: March 20, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)