Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 11:52 AM
Study NCT ID:
NCT05129605
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostate Cancer Genetic Risk Evaluation and Screening Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'C536928', 'term': 'Turcot syndrome'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Blood and urine on all subjects\n* Tumor tissue on subjects who develop prostate cancer'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-05', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of prostate cancer', 'timeFrame': 'From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first', 'description': 'Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer'}], 'secondaryOutcomes': [{'measure': 'Positive predictive value of multiparametric MRI for detection of prostate cancer', 'timeFrame': 'From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first', 'description': '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)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BRCA2', 'BRCA1', 'Mismatch Repair Deficiency', 'Lynch Syndrome', 'HOXB13', 'Family History of Prostate Cancer'], 'conditions': ['Prostatic Neoplasm', 'Prostate Cancer', 'BRCA2 Mutation', 'BRCA1 Mutation', 'ATM Gene Mutation', 'MMR Mutation', 'Lynch Syndrome', 'Genetic Predisposition to Disease']}, 'referencesModule': {'references': [{'pmid': '38412389', 'type': 'BACKGROUND', 'citation': 'Amini AE, Salari K. Incorporating Genetic Risk Into Prostate Cancer Care: Implications for Early Detection and Precision Oncology. JCO Precis Oncol. 2024 Feb;8:e2300560. doi: 10.1200/PO.23.00560.'}, {'pmid': '38453598', 'type': 'BACKGROUND', 'citation': "Amini AE, Hunter AE, Almashad A, Feng AJ, Patel ND, O'Dea MR, McCormick SR, Rodgers LH, Salari K. Magnetic Resonance Imaging-based Prostate Cancer Screening in Carriers of Pathogenic Germline Mutations: Interim Results from the Initial Screening Round of the Prostate Cancer Genetic Risk Evaluation and Screening Study. Eur Urol Oncol. 2024 Dec;7(6):1358-1366. doi: 10.1016/j.euo.2024.01.015. Epub 2024 Mar 6."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men 35-74 years old\n* No known diagnosis of prostate cancer\n* Life expectancy \\>10 years\n* Meet cohort A, B, or C criteria\n* 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)\n* Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing\n* Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment of prostate cancer\n* Inability to undergo prostate MRI\n* Inability to receive MRI contrast agent'}, 'identificationModule': {'nctId': 'NCT05129605', 'acronym': 'PROGRESS', 'briefTitle': 'Prostate Cancer Genetic Risk Evaluation and Screening Study', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)', 'orgStudyIdInfo': {'id': '2020P000081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene', 'interventionNames': ['Diagnostic Test: Prostate cancer screening']}, {'label': 'Cohort B', 'description': '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', 'interventionNames': ['Diagnostic Test: Prostate cancer screening']}, {'label': 'Cohort C', 'description': 'Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry', 'interventionNames': ['Diagnostic Test: Prostate cancer screening']}], 'interventions': [{'name': 'Prostate cancer screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Olympia Price', 'role': 'CONTACT', 'email': 'oprice@partners.org', 'phone': '857-238-3838'}], 'overallOfficials': [{'name': 'Keyan Salari, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urologic Oncology', 'investigatorFullName': 'Keyan Salari, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}