Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT04403568
Status:
WITHDRAWN
Last Update Posted:
2021-09-16
First Post:
2020-05-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097245', 'term': 'Ursolic Acid'}, {'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D053978', 'term': 'Pentacyclic Triterpenes'}, {'id': 'D014315', 'term': 'Triterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012502', 'term': 'Sapogenins'}, {'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects were enrolled in this study, the PI will seek funding and revise the protocol for resubmisson at a later date', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number, frequency, duration, and relation of toxicity events', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Safety will be compared to evaluate the number, frequency, duration, and relation of toxicity events to CURC/UA combination, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.'}, {'measure': 'Peak serum concentration', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.'}, {'measure': 'Time to reach peak serum concentration', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The pharmacokinetic parameter, the area under the curve (Tmax) representing the time it takes to reach Cmax of ursolic acid, curcumin, and their metabolites will be graphed.'}, {'measure': 'Half-life', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.'}], 'secondaryOutcomes': [{'measure': 'Levels of UA, CURC, and metabolites in prostate tissue', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Identify the presence and levels of UA, CURC and their metabolites in prostate tissue using HPLC.'}, {'measure': 'Immunohistochemistry measurement', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Immunohistochemistry of proportion of nuclear p65 NFkB staining before and after prostatectomy on FFPE samples will be completed.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radical Prostatectomy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect', 'detailedDescription': 'Once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (SOC) appointment or via telephone. Patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. Following informed consent, subjects will be assigned to one of the following cohorts:\n\nCohort 1:\n\n• Ursolic Acid (150 mg) BID (twice a day)\n\nCohort 2:\n\n• Curcumin (600 mg) BID\n\nCohort 3:\n\n• Ursolic Acid (150 mg) and Curcumin (600 mg) BID\n\nThe study team aim to enroll 10 subjects who will complete the study into each cohort for a total of 30 completers. Subjects will be enrolled on a rolling basis with the first ten subjects assigned to Cohort 1, the next ten subjects assigned to Cohort 2, and the last 10 subjects assigned to Cohort 3.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have proven diagnosis of prostate cancer with Gleason Group 3 or lower and planning to undergo radical prostatectomy\n* Be able to give informed consent\n* Be age 18 or older\n* Able to stop supplements\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Age \\< 18\n* High-risk prostate cancer or suspected metastasis\n* Unable to swallow pills\n* Unable to stop supplements'}, 'identificationModule': {'nctId': 'NCT04403568', 'briefTitle': 'Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate', 'orgStudyIdInfo': {'id': 'HSC20190735H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ursolic Acid', 'description': 'Administration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy', 'interventionNames': ['Drug: Ursolic Acid']}, {'type': 'EXPERIMENTAL', 'label': 'Curcumin', 'description': 'Administration of Curcumin to subjects who are scheduled to undergo radical prostatectomy', 'interventionNames': ['Drug: Curcumin']}, {'type': 'EXPERIMENTAL', 'label': 'Ursolic Acid and Curcumin', 'description': 'Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy', 'interventionNames': ['Drug: Ursolic Acid', 'Drug: Curcumin']}], 'interventions': [{'name': 'Ursolic Acid', 'type': 'DRUG', 'description': 'Ursolic Acid 150mg', 'armGroupLabels': ['Ursolic Acid', 'Ursolic Acid and Curcumin']}, {'name': 'Curcumin', 'type': 'DRUG', 'description': 'Curcumin 600mg', 'armGroupLabels': ['Curcumin', 'Ursolic Acid and Curcumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Mays Cancer Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Michael A Liss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'De-identified individual participant data will be available upon completion of the study for approx. 1 year.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be available upon request.', 'accessCriteria': 'Access granted upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}