Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-06 @ 1:19 AM
Study NCT ID:
NCT07454603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'WHOLE BLOOD'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy', 'timeFrame': 'Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.', 'description': 'Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Assay is scored 0-100 and has a cut-off of 50 for normal. A blood sample with a PROSTest score \\> or equal than 50 are predicted to be a prostate cancer. The expectation is that \\>85% of individuals who are biopsy positive are also PROSTest-positive. We anticipate \\~400 individuals will be biopsy positive. Conversely, the expectation is that \\>75% of individuals who are biopsy negative will also be PROSTest-negative. We anticipate \\~600 individuals will be biopsy negative. This will allow us to derive diagnostic metrics for the assay using biopsy-status as the gold standard.'}], 'secondaryOutcomes': [{'measure': 'Diagnostics metrics for the PROSTest', 'timeFrame': 'Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.', 'description': 'Secondary endpoint includes investigating whether there is a correlation between the PROSTest score (scaled 0-100) and the Gleason grade group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BIOPSY', 'MRI', 'PROSTATE CANCER'], 'conditions': ['Prostate Cancer', 'Urology', 'Prostate Cancer (Diagnosis)']}, 'referencesModule': {'references': [{'pmid': '41463159', 'type': 'BACKGROUND', 'citation': 'Rogers CG, Koduru SV, Gulati A, Halim AB. PROSTest, a Novel Liquid Biopsy Molecular Assay, Accurately Guides Prostate Cancer Biopsy Decision-Making in Men with Elevated PSA Irrespective of DRE Findings. Cancers (Basel). 2025 Dec 6;17(24):3908. doi: 10.3390/cancers17243908.'}, {'pmid': '41129487', 'type': 'BACKGROUND', 'citation': 'Kidd M, Rempega G, Kepinski M, Slomian S, Mlynarek K, Halim AB. Utility of the PROSTest, a Novel Blood-Based Molecular Assay, Versus PSA for Prostate Cancer Stratification and Detection of Disease. Prostate. 2026 Feb;86(3):307-313. doi: 10.1002/pros.70086. Epub 2025 Oct 23.'}, {'pmid': '40970770', 'type': 'BACKGROUND', 'citation': 'Rahbar K, Rosin RD, Kidd M, Halim AB, Sartor O. PROSTest, a Multigene Liquid Biopsy Signature, Effectively Stratifies Patients With High PSA for Prostate Biopsy. Prostate. 2026 Jan;86(1):43-52. doi: 10.1002/pros.70052. Epub 2025 Sep 19.'}, {'pmid': '39838708', 'type': 'BACKGROUND', 'citation': 'Rahbar K, Kidd M, Prasad V, David Rosin R, Drozdov I, Halim A. Clinical Sensitivity and Specificity of the PROSTest in an American Cohort. Prostate. 2025 May;85(6):558-566. doi: 10.1002/pros.24858. Epub 2025 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.', 'detailedDescription': 'This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology. Diagnostic performance metrics including sensitivity, specificity, negative predictive value, and area under the receiver operating characteristic curve will be calculated. Decision-curve analyses will assess potential reductions in unnecessary biopsies. Exploratory analyses will evaluate correlations between PROSTest scores, MRI findings, and pathologic grade group.\n\nEndpoints: Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Secondary endpoints include negative predictive value, correlation with Gleason grade group, and incremental performance of PROSTest when combined with PSA and MRI.\n\nTrial Status: IRB approval is complete. Enrollment is expected to begin in March 2026, with a planned sample size of approximately \\[1,500\\] participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men at risk for PCa based on age and or elevated PSA/abnormal DRE.', 'genderDescription': 'PROSTATE CANCER IS A MALE DISEASE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elevated PSA and/or abnormal digital rectal examination\n\nExclusion Criteria:\n\n* Previous Prostate cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT07454603', 'acronym': 'PROSTest_STRAT', 'briefTitle': 'A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wren Laboratories LLC'}, 'officialTitle': 'A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer', 'orgStudyIdInfo': {'id': 'WREN_REGISTER_03'}, 'secondaryIdInfos': [{'id': 'WREN_010', 'type': 'REGISTRY', 'domain': 'PROSTest_Stratification_Registry'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PROSTEST', 'type': 'DIAGNOSTIC_TEST', 'description': 'BLOOD SAMPLE FOR PROSTEST MEASUREMENT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06405', 'city': 'Branford', 'state': 'Connecticut', 'country': 'United States', 'contacts': [{'name': 'Mark Kidd, PhD', 'role': 'CONTACT', 'email': 'mkidd@wrenlaboratories.com', 'phone': '2038241128'}, {'name': 'Tracy Auster, BS', 'role': 'CONTACT', 'email': 'tauster@wrenlaboratories.com', 'phone': '2032083464'}], 'facility': 'Wren Laboratories', 'geoPoint': {'lat': 41.27954, 'lon': -72.8151}}], 'centralContacts': [{'name': 'Mark Kidd, PhD', 'role': 'CONTACT', 'email': 'mkidd@wrenlaboratories.com', 'phone': '2038241128'}, {'name': 'Tracy Auster, BS', 'role': 'CONTACT', 'email': 'tauster@wrenlaboratories.com', 'phone': '2032083464'}], 'overallOfficials': [{'name': 'Abdel Halim, PharmD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wren Laboratories'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are establishing a DFR for this.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wren Laboratories LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}