Prostatic Neoplasms Clinical Trial
Official title:
Observational Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy
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. ...
Status | Recruiting |
Enrollment | 345 |
Est. completion date | December 1, 2029 |
Est. primary completion date | April 1, 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 35 Years to 120 Years |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Provide a summary of the report to local health insurance companies | To provide data to insurers that supports reimbursement of MRI in men of African Ancestry in order to improve access to care. | End of study | |
Secondary | Sensitivity and Area under the curve (AUC) | To use and further develop artificial intelligence (AI) algorithms to predict for clinically significant prostate cancer in men of African Ancestry based on MRI and clinical features as well as genomic risk scores. | Study duration | |
Secondary | Prostate cancer status and overall survival in mid-term (5 years) follow up | To evaluate prostate cancer status and overall survival in mid-term (5 years) follow up course after baseline MRI | 5 years | |
Secondary | Genomic sequencing findings | To evaluate genomic sequencing of diagnosed tumors in men of African Ancestry and compare it to the population of self-referred participants to the NCI which is predominantly Caucasian. | Baseline visit 1 and visit 2. | |
Secondary | Polygenic risk score | To evaluate the predictive value of the polygenic risk score (PRS) in predicting clinically significant prostate cancer in men of African Ancestry. | Study duration |
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