Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-17 @ 12:39 PM
Study NCT ID:
NCT03177551
Status:
UNKNOWN
Last Update Posted:
2018-10-01
First Post:
2017-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Nomogram of CRPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to castration resistant', 'timeFrame': '3 YEARS', 'description': 'The definition mCRPC is that the castrated androgen \\< 50 ng/dL or 1.7 nmol/L plus either;\n\n1. Biochemical progression: Three consecutive rises in PSA one week apart resulting in two 50% increases over the nadir, and a PSA \\> 2 ng/mL or,\n2. Radiological progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using RECIST (Response Evaluation Criteria in Solid Tumours) \\[736\\].\n\nSymptomatic progression alone must be questioned and subject to further investigation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostatic Neoplasms', 'Nomograms', 'Drug Resistance, Neoplasm'], 'conditions': ['Castration-resistant Prostate Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.', 'detailedDescription': 'This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants having indication and planning to receiving ADT.', 'genderDescription': 'Male only', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who have given consent form;\n* Participants with pathologically defined prostate cancer;\n* Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment;\n* Participants having indication and planning to receiving ADT.\n\nExclusion Criteria:\n\n* Participants with previous history of ADT;\n* Participants who are allergic to contrast medium;\n* Participants who failed to regulate endocrine therapy with the orders requirements;"}, 'identificationModule': {'nctId': 'NCT03177551', 'acronym': 'CRPC-PN', 'briefTitle': 'Predictive Nomogram of CRPC', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Second Hospital'}, 'officialTitle': 'Development and Validation of Predictive Nomogram for Castration Resistant to Androgen Deprivation Therapy in Patients With Advanced Prostate Cancer', 'orgStudyIdInfo': {'id': 'CRPC-PN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Developement Cohort', 'description': 'Development the Predictive Nomogram for mCRPC in Patients with Prostate Cancer'}, {'label': 'Validation Cohort', 'description': 'Validation the Predictive Nomogram for mCRPC in Patients with Prostate Cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '300211', 'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Han', 'role': 'CONTACT', 'email': 'miyansuo@126.com', 'phone': '+86 022 8832 8677'}, {'name': 'Yuanjie Niu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shimiao Zhu, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tianjin Medical Unversity Second Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Shimiao Zhu, MD,PhD', 'role': 'CONTACT', 'email': 'zhushimiao@tijmu.edu.cn', 'phone': '+8613752436539'}], 'overallOfficials': [{'name': 'Yuanjie Niu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Second Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD could be got by contacting researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Second Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}