Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT03275857
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cisplatin in Castration Resistant Prostate Cancer
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': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to dosing differences of Cisplatin from lab and scan results', 'timeFrame': '2 years', 'description': 'Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases.'}, {'measure': 'Toxicity observed with dosing differences of Cisplatin', 'timeFrame': '2 years', 'description': 'Blood samples and physical assessments will be conducted and reviewed to determine toxicity of treatment. Toxicity would be symptoms such as ringing in the ears (tinnitus) peripheral neuropathy or lab findings such as rise in creatinine, electrolyte abnormalities such as low magnesium.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic diagnosis of prostate cancer\n* Age 18 yrs or older\n* Able to provide written, informed consent\n* Subjects who have received docetaxel for metastatic disease are eligible if absolute neutrophil count is greater than 100 and platelet count is greater than 100,000 and their bone marrow reserve is deemed to be adequate\n* Subjects with castration resistant prostate cancer, as defined by having testosterone level of less than 50 Nano gram/dl, being treated with enzalutamide with a rise in PSA, confirmed with a repeat measurement within 1 to four weeks, or asymptomatic radiographic progression\n\nExclusion Criteria:\n\n* Subjects with estimated glomerular filtration rate of less than 50 ml/min\n* Subjects with hearing impairment. The treating physician may decide which subjects should not receive cisplatin based on audiometry or based on clinical judgment.\n* Subjects with grade 2 or greater neuropathy\n* Subjects who in the opinion of the treating physician could not tolerate the standard hydration before receiving cisplatin\n* Chemotherapy naïve subjects who in the opinion of the treating physician should receive docetaxel instead of enrolling on the trial and receive cisplatin'}, 'identificationModule': {'nctId': 'NCT03275857', 'briefTitle': 'Cisplatin in Castration Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide', 'orgStudyIdInfo': {'id': 'UGUP-17050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cisplatin', 'interventionNames': ['Drug: Cisplatin']}], 'interventions': [{'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Weekly IV', 'armGroupLabels': ['Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Wilmot Cancer Institute', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Deepak Sahasrabudhe', 'investigatorAffiliation': 'University of Rochester'}}}}