Clinical trial · Observational
Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy
Observational Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Positive Digital Rectal Examination | — | UNRESOLVED | — |
| Prostate Specific Antigens | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Strong Family History of Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Participants of African Ancestry with elevated serum prostate specific antigen of (Bullet)3ng/ml or positive digital rectal examination or strong family history.
Primary outcomes (1)
- measure
- Cancer detection rate
- timeFrame
- mpMRI performed at baseline visit 1 and mpMRI guided biopsy performed within 6 months after that in participants with PI-RADS score >=3.
- description
- 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.
Secondary outcomes (5)
- measure
- Provide a summary of the report to local health insurance companies
- timeFrame
- End of study
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 120 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * 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. EXCLUSION CRITERIA: * 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.
References
Publications (0)
Data not yet available