Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05872503
Other study ID # 10001567
Secondary ID 001567-C
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2024
Est. completion date December 1, 2029

Study information

Verified date June 3, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Yolanda McKinney, R.N.
Phone (240) 760-6095
Email ymckinney@mail.nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. ...


Description:

Background: - Prostate cancer (PCa) is the most common non-dermatologic malignancy among American men and is a leading cause of cancer mortality. Men of African Ancestry (AA) have a 1.8- fold higher incidence of prostate cancer and a 2.2-fold higher likelihood of death when compared to men of European Ancestry. The predominant factor in the increased death rate is the increased incidence of cancer. The underlying reasons for the increase in incidence are controversial but likely include genetic and environmental factors. - One strategy to counteract the effects of increased cancer incidence in a given patient population is to utilize earlier and/or more intense screening as it leads to earlier diagnosis and potentially better outcomes. - Multiparametric MRI (mpMRI) is a proven useful tool in the diagnosis of prostate cancer but access to high quality mpMRI in communities of color is often limited. - For individuals who are members of communities of color, high quality prostate MRI is a limited resource and insurance coverage is often denied. Given the high risk of prostate cancer in these communities, the benefits of screening with mpMRI and mpMRI guided biopsies could be significant as it could enable earlier diagnosis. Objective: -To compare results of mpMRI and mpMRI guided biopsy in diagnosing clinically significant prostate cancer between men of African Ancestry 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 of European Ancestry. Eligibility: - Age >35 years - Self-identified men of African Ancestry - Elevated serum prostate specific antigen (PSA) of >=3ng/ml and/or positive digital rectal examination and/or strong family history of cancer Design: - This is a prospective single arm observational study. - Up to 345 prostate biopsy na(SqrRoot) ve participants will be recruited to evaluate the use of mpMRI and mpMRI guided biopsy in diagnosing localized clinically significant prostate cancer among men of African Ancestry. - Study participants will be referred by hospitals that mainly provide medical care for communities of color (e.g., Howard University Hospital, Washington Hospital Center). - Participants will undergo a state-of-the-art mpMRI of the prostate in the Molecular Imaging Branch, NCI. - If a suitable lesion (Prostate Imaging Reporting and Data System (PI-RADS >=3) is identified, mpMRI/transrectal ultrasound (TRUS) fusion guided and standard of care systematic TRUS guided biopsies of the prostate will be performed within 6 months after the mpMRI. Participants with no PI-RADS score >=3 lesions at baseline mpMRI will not have a biopsy but will be followed for 5 years. - Participants with a positive baseline mpMRI will be in follow-up for 5 years and have phone/virtual visits occurring annually. Prostate cancer related records and overall 5 year survival status of the participants will be monitored during these follow up visits. If clinically indicated and per referring physician, additional follow up MRIs and PSAs may be obtained annually or bi-annually.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04964271 - Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
Completed NCT02546908 - A Registry of Participants With Prostate Cancer in Asia
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT01683994 - Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer Phase 1/Phase 2
Completed NCT04838613 - Study of Diagnostic Performance of [18F]CTT1057 in BCR Phase 3
Completed NCT02364531 - A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
Completed NCT01929655 - Japanese BAY88-8223 Monotherapy Phase II Study Phase 2
Active, not recruiting NCT05022849 - A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants Phase 1
Completed NCT03261999 - Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer Phase 3
Terminated NCT04907227 - Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension Phase 3
Active, not recruiting NCT03587285 - A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer Phase 1/Phase 2
Completed NCT02217566 - Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy Phase 2
Not yet recruiting NCT04101305 - Measurement of Circulating Tumor Cells in Prostate Cancer
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Withdrawn NCT02905201 - A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) N/A
Terminated NCT03066154 - Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer Phase 1
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Terminated NCT01420965 - Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer Phase 2
Completed NCT01441713 - Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer N/A