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NCT Number: NCT05129605

Prostate Cancer Genetic Risk Evaluation and Screening Study

This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.

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Key information

Conditions

Prostatic Neoplasm ATM Gene Mutation BRCA1 Mutation BRCA2 Mutation Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Susceptibility Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genetic Predisposition to Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lynch Syndrome MMR Mutation Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Turcot syndrome Urogenital Diseases Urogenital Neoplasms

Age range

35 year–74 year

Sex eligibility

Male

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

About this study

Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men. Prostate cancer has substantial inherited predisposition and men harboring specific genetic variants or a positive family history have been associated with an increased risk of developing prostate cancer. Men with specific genetic variants, such as pathogenic BRCA2 mutations, are at particularly greater risk of developing aggressive forms of prostate cancer and thus warrant undergoing careful screening for prostate cancer. However, the penetrance of many mutations in prostate cancer risk genes is unknown, and some men have no identifiable mutations in known risk genes despite a strong family history of prostate cancer. Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance the understanding of how specific mutations contribute to the development of prostate cancer and how these prostate cancers might be best detected. The purpose of this study is to prospectively screen men at high risk genetic risk for prostate cancer by prostate exam, PSA, and prostate MRI to characterize the penetrance and cancer-related outcomes of specific mutations, identify potentially novel genetic risk mutations and/or markers for early detection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men 35-74 years old
  • No known diagnosis of prostate cancer
  • Life expectancy >10 years
  • Meet cohort A, B, or C criteria
  • Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
  • Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
  • Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Exclusion criteria

  • Prior diagnosis or treatment of prostate cancer
  • Inability to undergo prostate MRI
  • Inability to receive MRI contrast agent

Treatment and study plan

Prostate cancer screening

Diagnostic Test

Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate

Primary outcomes

  1. Diagnosis of prostate cancer

    Time frame: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first

    Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer

Secondary outcomes

  1. Positive predictive value of multiparametric MRI for detection of prostate cancer

    Time frame: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first

    Positive predictive value of multiparametric prostate MRI for detecting clinically significant prostate cancer in men at high genetic risk for prostate cancer with a positive MRI (PI-RADS score of 3 or higher)

Study contacts

Contact information is provided by the study sponsor or research team.

Olympia Price

CONTACT

[email protected]

857-238-3838

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

Acronym: PROGRESS

Important dates

Study start
2020
Primary completion
2030
Study completion
2040
First posted
Nov 22, 2021
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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