Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05872503
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-05-20
Brief Title:
Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Observational Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor their local doctors will be contacted once a year for follow-up Additional mpMRIs may be recommended
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 andor 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 andor their local doctors will be contacted once a year for follow-up Additional mpMRIs may be recommended
Detailed 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 18- fold higher incidence of prostate cancer and a 22-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 andor 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 eg 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 3ngml andor positive digital rectal examination andor strong family history of cancer
Design
This is a prospective single arm observational study
Up to 345 prostate biopsy naSqrRoot 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 eg 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 mpMRItransrectal 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 phonevirtual 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
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 18- fold higher incidence of prostate cancer and a 22-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 andor 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 eg 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 3ngml andor positive digital rectal examination andor strong family history of cancer
Design
This is a prospective single arm observational study
Up to 345 prostate biopsy naSqrRoot 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 eg 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 mpMRItransrectal 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 phonevirtual 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001567-C | None | None | None |