Prostate Cancer Genetic Risk Evaluation and Screening Study

Prostate Cancer Clinical Trial

— PROGRESS  

Official title:

Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129605
• Other study ID #: 2020P000081
• Status: Recruiting
• Start date: February 12, 2020
• Est. completion date: December 2040

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Olympia Price
• Phone: 857-238-3838
• Email: oprice[@]partners.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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 or a positive family history 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2040
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 74 Years

Eligibility

Inclusion Criteria:

• Men 35-74 years old

• No known diagnosis of prostate cancer

• Life expectancy >10 years

• Meet either cohort A or B 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

Exclusion Criteria:

• Prior diagnosis or treatment of prostate cancer

• Inability to undergo prostate MRI

• Inability to receive MRI contrast agent

Related Conditions & MeSH terms

• ATM Gene Mutation
• BRCA1 Mutation
• BRCA2 Mutation
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Genetic Predisposition to Disease
• Lynch Syndrome
• Prostate Cancer
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Prostate cancer screening
Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of prostate cancer	Diagnosis of prostate cancer stratified by NCCN clinical risk category incorporating clinical stage, grade, and PSA at diagnosis.	From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first, assessed up to 20 years
Secondary	Positive predictive value of multiparametric MRI for detection of prostate cancer	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)	From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first, assessed up to 20 years