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Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

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ClinicalTrials.gov Identifier: NCT05129605
Recruitment Status : Recruiting
First Posted : November 22, 2021
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Keyan Salari, MD, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date November 2, 2021
First Posted Date November 22, 2021
Last Update Posted Date March 15, 2023
Actual Study Start Date February 12, 2020
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2021)
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, assessed up to 20 years ]
Diagnosis of prostate cancer stratified by NCCN clinical risk category incorporating clinical stage, grade, and PSA at diagnosis.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 9, 2021)
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, assessed up to 20 years ]
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate Cancer Genetic Risk Evaluation and Screening Study
Official Title Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
Brief 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.
Detailed 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 20 Years
Biospecimen Retention:   Samples With DNA
Description:
  • Saliva, blood, and urine on all subjects
  • Tumor tissue on subjects who develop prostate cancer
Sampling Method Non-Probability Sample
Study Population Men ages 35-74 years old at high genetic risk for prostate cancer on the basis of a specific germline genetic mutation or a strong family history.
Condition
  • Prostatic Neoplasm
  • Prostate Cancer
  • BRCA2 Mutation
  • BRCA1 Mutation
  • ATM Gene Mutation
  • MMR Mutation
  • Lynch Syndrome
  • Genetic Predisposition to Disease
Intervention Diagnostic Test: Prostate cancer screening
Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate
Study Groups/Cohorts
  • Cohort 1
    Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene
    Intervention: Diagnostic Test: Prostate cancer screening
  • Cohort 2
    Family history suggestive of high genetic risk for prostate cancer with clinical genetic testing negative for known pathogenic or likely pathogenic mutations in prostate cancer-related risk genes
    Intervention: Diagnostic Test: Prostate cancer screening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 9, 2021)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2040
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Men 35-74 years old
  • No known diagnosis of prostate cancer
  • Life expectancy >10 years
  • Meet either cohort 1 or 2 criteria
  • Cohort 1: 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 2: 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 35 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Olympia Price 857-238-3838 oprice@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05129605
Other Study ID Numbers 2020P000081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Keyan Salari, MD, PhD, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor Massachusetts General Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Keyan Salari, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2023