Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-03-01 @ 10:08 AM
Study NCT ID:
NCT02615067
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2015-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595576', 'term': 'technetium 99m 1-(1-(2-(bis(carboxymethyl)amino)-2-oxoethyl)-1H-imidazol-2-yl)-2-((1-(2-(bis(carboxymethyl)amino)-2-oxoethyl)-1H-imidazol-2-yl)methyl)-9,14-dioxo-2,8,13,15-tetraazaoctadecane-7,12,16,18-tetracarboxylic acid)'}, {'id': 'C031101', 'term': 'lortalamine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 531}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2019-03-05', 'completionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2015-11-20', 'dispFirstSubmitQcDate': '2019-03-05', 'studyFirstSubmitQcDate': '2015-11-23', 'dispFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]', 'timeFrame': 'Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken', 'description': 'Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes, if applicable, (as determined by histopathology) in patients undergoing RP (with or without extended pelvic lymph node dissection) or routine prostate biopsy. Pathology results will be used as the truth standard for all imaging analyses.'}, {'measure': 'Sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B]', 'timeFrame': 'Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken', 'description': 'Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes (as determined by histopathology) in patients undergoing standard of care prostatectomy with or without extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]', 'timeFrame': 'Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken', 'description': 'Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)'}, {'measure': 'Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]', 'timeFrame': 'Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken', 'description': 'Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology)'}, {'measure': 'Clinical safety of 99mTc-MIP-1404', 'timeFrame': 'Changes in vital signs and clinical laboratory test results from time of screening until pre-surgery (Day 0 - 42). Treatment-emergent adverse events from study drug injection until pre-surgery or pre-biopsy (within 42 days)', 'description': 'Clinical laboratory tests will include hematology and clinical chemistry. Vital signs will include heart rate, blood pressure, temperature and respiration rate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diagnostic', 'Active surveillance', 'Very low risk', 'Imaging', 'PSMA', 'SPECT/CT', '99mTc', 'Newly Diagnosed', 'Prostatectomy', 'Biopsy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '25342385', 'type': 'BACKGROUND', 'citation': 'Vallabhajosula S, Nikolopoulou A, Babich JW, Osborne JR, Tagawa ST, Lipai I, Solnes L, Maresca KP, Armor T, Joyal JL, Crummet R, Stubbs JB, Goldsmith SJ. 99mTc-labeled small-molecule inhibitors of prostate-specific membrane antigen: pharmacokinetics and biodistribution studies in healthy subjects and patients with metastatic prostate cancer. J Nucl Med. 2014 Nov;55(11):1791-8. doi: 10.2967/jnumed.114.140426. Epub 2014 Oct 23.'}, {'pmid': '23463331', 'type': 'BACKGROUND', 'citation': 'Eder M, Eisenhut M, Babich J, Haberkorn U. PSMA as a target for radiolabelled small molecules. Eur J Nucl Med Mol Imaging. 2013 Jun;40(6):819-23. doi: 10.1007/s00259-013-2374-2. No abstract available.'}, {'pmid': '23733925', 'type': 'BACKGROUND', 'citation': 'Hillier SM, Maresca KP, Lu G, Merkin RD, Marquis JC, Zimmerman CN, Eckelman WC, Joyal JL, Babich JW. 99mTc-labeled small-molecule inhibitors of prostate-specific membrane antigen for molecular imaging of prostate cancer. J Nucl Med. 2013 Aug;54(8):1369-76. doi: 10.2967/jnumed.112.116624. Epub 2013 Jun 3.'}]}, 'descriptionModule': {'briefSummary': '99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) \\[Cohort A\\] or routine prostate biopsy \\[Cohort B\\]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.', 'detailedDescription': 'This is a multi-center, multi-reader, open-label trial, comparing 99mTc-MIP-1404 SPECT/CT imaging in men who have had a diagnostic trans-rectal ultrasound (TRUS) guided biopsy with a histopathologic finding of Gleason score ≤3+4 who are candidates for active surveillance and are undergoing routine biopsy or voluntary RP with or without a pelvic lymph node dissection (PLND). This study will evaluate the sensitivity and specificity of 99mTc-MIP-1404 SPECT/CT image assessments to correctly identify subjects with previously unknown clinically significant prostate cancer in two cohorts: (1) Low grade prostate cancer who have elected to undergo RP \\[Cohort A\\]; and (2) very low risk (VLR) prostate cancer per 2016 NCCN Guidelines who are scheduled to undergo routine prostate biopsy \\[Cohort B\\].\n\nSubjects will receive a single dose of 99mTc-MIP-1404 Injection (study drug) followed by whole body planar and SPECT/CT (pelvic) imaging 3-6 hours after injection. In accordance with standard of care procedures, subjects will undergo either voluntary RP \\[Cohort A\\] or prostate biopsy \\[Cohort B\\] within 42 days after study drug dosing. 99mTc-MIP-1404 image data will be collected by a central imaging core laboratory and evaluated for visible uptake within the prostate gland. These findings will then be compared against central histopathology as the truth standard. The central imaging core lab independent readers for the SPECT/CT scans will be blinded to all clinical data, including pathology results. Likewise, central pathologists are to remain blinded to all clinical data, including imaging results.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Ability to provide informed consent and willingness to comply with protocol requirements\n* Life expectancy ≥ 6 months\n\nCohort A only:\n\n* A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of enrollment showing adenocarcinoma of the prostate gland\n* Within 90 days of consent, serum PSA ≤ 15.0 ng/mL or ≤ 7.5 ng/mL if on 5 α-reductase inhibitors.\n* Candidates for active surveillance and/or a Gleason score ≤3+4\n* Scheduled to undergo radical prostatectomy (RP) with or without pelvic lymph node dissection (PLND)\n\nCohort B only:\n\n* Very low risk (VLR) prostate cancer defined by 2016 NCCN Guideline criteria:\n* T1c stage, and\n* PSA \\< 10 ng/mL, and\n* Gleason score ≤ 6 with \\< 3 biopsy cores cancer positive and ≤ 50% cancer in any core based on prior prostate biopsy within 24 months of enrollment, and\n* PSA density \\< 0.15 mg/mL/g\n* Scheduled to undergo a reassessment of prostate cancer staging that includes prostate biopsy as part of routine follow-up\n\nEXCLUSION CRITERIA:\n\n1. Subjects administered a radioisotope within 5 physical half-lives prior to study drug injection.\n2. Previous treatment with hormonal therapy, surgery (except biopsy), radiation therapy, LHRH analogs, and non-steroidal anti-androgens, for the treatment of prostate cancer or benign prostatic hyperplasia (BPH)\n3. Planned androgen or anti-androgen therapy prior to RP surgery or biopsy\n4. Subjects with any medical condition or other circumstances that, in the opinion of the investigator, would significantly interfere with obtaining reliable data, achieving study objectives, or completing the study\n5. Malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (Ta stage transitional cell carcinoma bladder cancer with negative surveillance cystoscopy within the past 2 years may be included).'}, 'identificationModule': {'nctId': 'NCT02615067', 'acronym': 'proSPECT-AS', 'briefTitle': 'Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molecular Insight Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance (proSPECT-AS)', 'orgStudyIdInfo': {'id': 'MIP-1404-3301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '99mTc-MIP-1404 Injection', 'description': '20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404', 'interventionNames': ['Drug: 99mTc-MIP-1404 Injection', 'Diagnostic Test: Whole-Body Planar and pelvic SPECT/CT scan']}], 'interventions': [{'name': '99mTc-MIP-1404 Injection', 'type': 'DRUG', 'otherNames': ['1404'], 'description': 'A single dose of 20 (±3) mCi intravenous (IV) injection of 99mTc-MIP-1404.', 'armGroupLabels': ['99mTc-MIP-1404 Injection']}, {'name': 'Whole-Body Planar and pelvic SPECT/CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'A whole-body planar and pelvic SPECT/CT scan will be obtained 3-6 hours after injection of 99mTc-MIP-1404.', 'armGroupLabels': ['99mTc-MIP-1404 Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33612', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Urology Partners - Tampa Bay', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Morton Plant Hospital', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'University of Georgia / Regents Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Science Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20832', 'city': 'Olney', 'state': 'Maryland', 'country': 'United States', 'facility': 'Montgomery General Hospital', 'geoPoint': {'lat': 39.15316, 'lon': -77.06692}}, 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'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Peggy and Charles Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Urologic Consultants of Southeastern PA, LLP', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '19104-2640', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19046', 'city': 'Rockledge', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 40.08122, 'lon': -75.08962}}, {'zip': '29435', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington School of Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'T2V 1P9', 'city': 'Calgary, AB', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Prostate Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V7L 2L7', 'city': 'North Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Lions Gate Hospital', 'geoPoint': {'lat': 49.31636, 'lon': -123.06934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Cancer Care Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Cancer Care Nova Scotia', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute, University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier de l'Université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'MUHC', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre d'imagerie moléculaire de Sherbrooke", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'Hôtel-Dieu de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'William Ellis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molecular Insight Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}