Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Stefan Ambs, Ph.D.

This study will examine the association of genetic variants and gene expression patterns with the risk of prostate cancer. There will be (It will include?) genotype analysis of blood DNA from 600 patients with the disease and from 600 healthy people, and there will be a gene expression analysis of prostate tumors. Prostate cancer is a leading cause of death among men in Western countries. It is estimated that 220,000 or more new cases of the disease will occur in the United States during 2004. The disease incidence is rising. About 25% to 30% of the cancers become aggressive. The nonhereditary disease rarely occurs in men who are younger than age 40. There are large differences in incidence by geography and race. The highest rates are seen among African-American men in the United States. Also, although Caucasians have a lower rate of disease incidence and mortality in the United States, the rates among them are high compared with rates in some European countries. The reasons for such differences are not well understood, but both environmental and genetic risk factors are thought to be involved.

Patients ages 40 to 80 years who have had prostate cancer confirmed within the past 6 months, who reside in Baltimore City or adjacent metropolitan counties, and who were born in the United States may be eligible for this study. They will be recruited in collaboration with the Departments of Pathology and Urology at the University of Maryland and the Baltimore Veterans Affairs Medical Center. Those men serving as controls in this study will be identified through the Department of Motor Vehicles database and will be matched by age and race with the patients who have cancer. The study will include 600 participants with prostate cancer and 600 participants in the control group.

Trained interviewers will administer two questionnaires. The primary questionnaire will be used to assess information such as medical and cancer history, tobacco use, current medications, occupational history, family medical history, and socioeconomic status. A supplemental questionnaire will pertain to patients' exposure to risk factors for prostate cancer. It will assess the human body, diet, medical history, family medical history, and sexual history. The section on sexual history will be self-administered.

Patients will undergo collection of blood and urine for various tests. For cancer patients with prostate surgery, there will also be a collection of tissue, to be performed at the time that the prostate gland is scheduled for surgical removal. The pattern of gene expression will be analyzed in low- and high-stage tumors.

There will be no direct benefit from participating in the study, but participants will receive an incentive of up to $75 to participate in the study. No form of treatment is involved in this study. However, it is hoped that the study findings will improve researchers' understanding of prostate cancer biology with respect to the causes of the health variances between African-Americans and Caucasians.

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We are conducting an epidemiological prostate cancer case-control study in Baltimore, Maryland. Participants will be African American and Caucasian males who reside in Baltimore city and surrounding areas. The study is ongoing and will recruit 1000 prostate cancer cases and 1000 population-based controls. The cases are recruited at two Baltimore hospitals, the Veterans Affairs Medical Center and the University of Maryland Center. Cases will have pathologically confirmed prostate cancer. The population-based controls are identified through the Maryland Department of Motor Vehicle Database, and are frequency-matched by age and race to cases. Enrollment of controls started concurrently with case accrual. The first 12 months of the study constituted a pilot study, during which we evaluated the recruitment procedures. The study involves the administration of two questionnaires and collection of blood from all study subjects. The two questionnaires consist of a main questionnaire and a supplemental questionnaire. The questionnaires evaluate family cancer history, tobacco use, medication, occupational history, socioeconomic status and risk factors for prostate cancer. Fresh-frozen tumor specimens will be obtained from cancer patients if available. The study is supported by an epidemiological infrastructure that has been developed by our resource contractor at the University of Maryland for a lung cancer case-control study. This lung cancer study is ongoing, and the controls that are recruited for the prostate cancer study are joint controls with the lung cancer study. Hence, population-based male controls recruited by our contractor have double eligibility for the concurrent lung and prostate cancer studies. To achieve an age and race matching of cases and controls in the prostate study, we will over-sample male controls in the lung study.

We will test the primary hypothesis that genes and environmental exposures, including infections and medical history, and interactions between those exposures and genetic factors modify prostate cancer susceptibility. As the secondary goal, we will study gene expression profiles of prostate tumors to identify changes in tumor biology that are associated with exposure to genetic and environmental risk factors. It is a focus of this research to identify mechanisms in tumor biology that may cause the aggressive nature of prostate cancer in African American men.

An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males

A Case-Control Study of Prostate Cancer in the Greater Baltimore Area: An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males

association of tobacco use, obesity, inflammation and anti- inflammatory drugs, sexual activity and sexually transmitted diseases, and ancestral markers with prostate cancer and lethal disease

association of blood and/or urine-based metabolites, and blood-based immune- inflammation markers with either ancestry, lifestyle factors, prostate cancer, and lethal disease.

National Cancer Institute (NCI)

The Prostate Cancer Genius app includes the following components: (1) educational content that is consistent with existing evidence and recommendations for prostate cancer and prostate cancer screening but has been adapted for the African American male population and for adults who read at or below the 8th-grade level; (2) real-time messages about the risks of prostate cancer and the benefits of completing a PSA test, placing a special emphasis on screening considerations for individuals with a family history of prostate cancer and/or lower urinary tract symptoms (measured via the American Urological Association Symptom Score); (3) general trivia that also incorporates quiz questions about prostate cancer and the PSA test; (4) African American-specific testimonials and educational videos; (5) optional counseling by African American prostate cancer survivors; and (6) on-demand, automated ordering of a home-based PSA test.

The Prevention Taskforce app provides on-demand access to evidence-based recommendations for prostate cancer for men between 55 and 69 (i.e., it can be accessed as needed).

Participants assigned to use the Prostate Cancer Genius App will receive a combination of (a) scheduled and (b) on-demand content prostate cancer for one month. Scheduled content will be delivered on specific days each week using app notifications. Participants will also receive tailored navigation for ordering a home-based PSA kit, including receiving follow-up information from trained medical professionals about their test results.

Prostate Cancer Genius App

Participants assigned to use the US Prevention Task Force app will download the app from Google Play and will be instructed to use the app for one-month to to become more informed about prostate cancer. They will also be instructed to download a companion app from the Google Play store. This companion app will be used to deliver weekly assessments and order a home-based PSA test kit if the participant chooses to so. Participants assigned to the Prevention Taskforce app will receive a brochure providing details about the purpose of the home-based PSA test.

US Prevention Taskforce App

Adam C Alexander, PhD

Ashley Krukowski, MPA, CRA

Adam Alexander, PhD

Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. To address this inequity, innovative team science approaches are required. This project proposes to develop and test the first-of-its-kind Prostate Cancer Genius App to improve knowledge of prostate cancer risk and symptoms, and deliver tailored navigation to complete a home-based PSA test. The primary goal of this study is to evaluate the feasibility of the Prostate Cancer Genius App in a 30-day pilot randomized control trial compared to an existing app developed by the U.S. Department of Health \& Human Services (Prevention Taskforce App). African American men from Oklahoma, aged between 55 and 69 (N = 80), eligible for the PSA test will be randomly assigned 1:1 to receive either app. Three dimensions of app feasibility will be assessed: (1) preliminary efficacy, evaluated via post-intervention differences in prostate cancer knowledge, (2) app engagement and accessibility, measured via self-report questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. Finally, the investigative team will explore post-intervention PSA screening rates and identify predictors of screening/not screening across both arms. The successful demonstration of feasibility for the Prostate Cancer Genius App within Oklahoma will support expanding this intervention to African Americans nationwide.

Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. Disparities in prostate cancer for African American men have persisted for almost half a century, and these health disparities are among the most extreme of all cancers in the United States. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. The process of informed and effective decision-making is heavily underpinned by adequate knowledge levels of the disease and screening benefits and risks, with lower knowledge levels reported among African American men. This project will test the feasibility of a first-of-its-kind Prostate Cancer Genius App (herein referred to as Genius App) to improve knowledge of prostate cancer risk and symptoms. PSA testing is not appropriate for all men, so the Genius App will support informed decision-making with a healthcare provider. The Genius App will also provide novel tailored navigation to complete a home-based PSA test for men who opt to screen. To test the app, 80 African American men from Oklahoma (aged 55 and 69) who are not up to date with PSA screening will be randomly assigned 1:1 to use either the Genius app or an existing U.S. Department of Health \& Human Services app (herein referred to as the Prevention Taskforce App) for 30 days.

Aim 1. Evaluate the preliminary efficacy of a prostate cancer prevention app on prostate cancer knowledge (primary outcome).

Hypothesis: Participants (n = 40) randomly assigned to the Genius app will report significantly greater knowledge about prostate cancer post-intervention than participants (n = 40) randomly assigned to the Prevention Taskforce‬ app at 30 days post-randomization.

Aim 2. Explore the perceived engagement, accessibility, and acceptability of a prostate cancer prevention app.

The investigative team will explore: (i) the extent to which participants find the Genius App engaging and accessible compared to the Prevention Taskforce‬ app via validated self-report questionnaires and app metadata; and (ii) the perceived acceptability of the Genius App by conducting semi-structured interviews (n=40) with participants to acquire in-depth descriptions of their experiences with the app at the end of the study.

Aim 3. Derive preliminary estimates of the effects of a Genius App on PSA screening test completion rates and identify mechanisms of screening adherence.

The investigative team will (i) explore differences in PSA test completion rates, including in-clinic and home-based PSA testing, between the Genius app and the Prevention Taskforce‬ app and (ii) identify whether changes in key variables in weekly smartphone assessments predict completing a PSA test.

Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men

A Pilot Randomized Clinical Trial of a Smartphone-based Application for Prostate Cancer Education and Home-based PSA Screening for African American Men

All participants will complete a baseline survey and a post-intervention survey via REDCap. Baseline and post-intervention assessments will measure prostate cancer risk and screening knowledge using the Prostate Cancer Knowledge Scale.The scale consists of 18 items that assess screening (6 items), risk factors (5 items), and warning signs (7 items) of prostate cancer. This scale has strong internal consistency (α = .80) and has been validated for use in the African American population.

Home-based PSA test completion rates will be analyzed four weeks after enrollment via documented receipt of the kit. We will also measure the number of participants who (a) scheduled a visit with their provider, (b) reported shared decision making with their provider, and (c) self-report completing a clinic-based PSA test. To verify, participants will have the option to upload a copy of their results to verify self-report data.

University of Oklahoma

Participants of African Ancestry with elevated serum prostate specific antigen of (Bullet)3ng/ml or positive digital rectal examination or strong family history.

Yolanda McKinney, R.N.

Ismail B Turkbey, M.D.

National Cancer Institute Referral Office

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.

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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.

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

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

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.

To provide data to insurers that supports reimbursement of MRI in men of African Ancestry in order to improve access to care.

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.

To evaluate prostate cancer status and overall survival in mid-term (5 years) follow up course after baseline MRI

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.

To evaluate the predictive value of the polygenic risk score (PRS) in predicting clinically significant prostate cancer in men of African Ancestry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males	NCT00342771	Prostate Cancer		40 Years - 90 Years	National Institutes of Health Clinical Center (CC)
An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males	NCT00342771	Prostate Cancer		40 Years - 90 Years	National Institutes of Health Clinical Center (CC)
Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men	NCT05331638	Prostate Cancer Health Behavior	Prostate Cancer... US Prevention T...	55 Years - 69 Years	University of Oklahoma
Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy	NCT05872503	Prostate Specif... Positive Digita... Strong Family H... Prostatic Neopl...		35 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men	NCT05331638	Prostate Cancer Health Behavior	Prostate Cancer... US Prevention T...	55 Years - 69 Years	University of Oklahoma
Study of Rates of Prostate Cancer Diagnosis in Men of African Ancestry Using MRI and MRI Guided Biopsy	NCT05872503	Prostate Specif... Positive Digita... Strong Family H... Prostatic Neopl...		35 Years - 120 Years	National Institutes of Health Clinical Center (CC)

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