This study is currently recruiting participants.
Number
001567-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male Min Age: 35 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Female;Children
Keywords
Health Disparity; Multiparametric MRI; MRI-Guided Biopsy; Prostate Cancer
Recruitment Keyword(s)
None
Condition(s)
Prostate Specific Antigens; Positive Digital Rectal Examination; Strong Family History of Prostate Cancer; Prostatic Neoplasms
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
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.
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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.
-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.
Principal Investigator
Referral Contact
For more information: