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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 : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Keyan Salari, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Prostatic Neoplasm Prostate Cancer BRCA2 Mutation BRCA1 Mutation ATM Gene Mutation MMR Mutation Lynch Syndrome Genetic Predisposition to Disease Diagnostic Test: Prostate cancer screening

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Cohort 1
Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene
Diagnostic Test: Prostate cancer screening
Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate

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




Primary Outcome Measures :
  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, assessed up to 20 years ]
    Diagnosis of prostate cancer stratified by NCCN clinical risk category incorporating clinical stage, grade, and PSA at diagnosis.


Secondary Outcome Measures :
  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, 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)


Biospecimen Retention:   Samples With DNA
  • Saliva, blood, and urine on all subjects
  • Tumor tissue on subjects who develop prostate cancer


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05129605


Contacts
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Contact: Felicia Mett 857-238-3838 fmett@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Keyan Salari, MD, PhD Massachusetts General Hospital
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Responsible Party: Keyan Salari, MD, PhD, Urologic Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05129605    
Other Study ID Numbers: 2020P000081
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keyan Salari, MD, PhD, Massachusetts General Hospital:
BRCA2
BRCA1
Mismatch Repair Deficiency
Lynch Syndrome
HOXB13
Family History of Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Disease Susceptibility
Genetic Predisposition to Disease
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Disease Attributes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases