Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-04 @ 1:35 AM
Study NCT ID:
NCT03507595
Status:
UNKNOWN
Last Update Posted:
2018-04-25
First Post:
2018-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Metastasis and Recurrence of 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-01', 'size': 66880, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-04-13T09:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-PSMA PET/CT imaging', 'timeFrame': '4 hours', 'description': 'The outcome of 18F-PSMA PET/CT imaging.'}], 'secondaryOutcomes': [{'measure': 'Bone scan imaging', 'timeFrame': '6 hours', 'description': 'The outcome of bone scan imaging.'}, {'measure': 'MRI imaging', 'timeFrame': '4 hours', 'description': 'The outcome of MRI imaging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate specific membrane antigen(PMSA)', 'prostate cancer', 'PET/CT'], 'conditions': ['Prostate Cancer (Diagnosis)', 'Prostate Cancer Metastatic', 'Prostate Cancer Recurrent', 'Prostate Cancer Stage']}, 'descriptionModule': {'briefSummary': 'This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.', 'detailedDescription': 'This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.And make some comparison with those 3 methods.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Patients with initial diagnosis of prostate cancer;\n* Patients with biochemical recurrent prostate cancer;\n* Patients with CRPC.', 'genderDescription': 'Aged male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with initial diagnosis of prostate cancer; 1）T2 stage: PSA\\>20ng/ml, Gleason Score \\>= 8; 2）T3 or T4 stage; 3）The imaging examination was negative or localized metastasis of the pelvic lymph node, but there was no distant metastasis of lymph nodes or bone and internal organs other than the pelvic cavity.\n2. Patients with biochemical recurrent prostate cancer; 1）After the RRP surgery, the serum PSA was over 0.2 ng/ml in two consecutive sera; 2）After the radiotherapy: the lowest PSA is up to 2 ng/ml.\n3. Patients with CRPC. 1）The serum testosterone is in the castration level (\\< 50 ng/dL or \\< 1.7 nmol/L); 2）The PSA is elevated 3 times in a row, the base value is increased by more than 50%, and the PSA \\> 2ng/mL(the interval is one week); 3）The continuation of the anti-androgen drugs, flunamine was stopped for at least 4 weeks, and biglumide was suspended for at least 6 weeks; 4）Despite the continued standard androgen deprivation therapy, the PSA is still progressing.\n\nExclusion Criteria:\n\n1. Patients who are unwilling to participate in the study or unwilling to sign the informed consent forms;\n2. Patients who are critically ill, suffering from mental illness and cannot cooperate with the examination;\n3. There are electronic implants, such as pacemakers and insulin pumps in the body, and magnetic metal foreign objects in the spot.'}, 'identificationModule': {'nctId': 'NCT03507595', 'briefTitle': 'Evaluation of the Metastasis and Recurrence of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Evaluation of the Metastasis and Recurrence of Prostate Cancer With 18F-PSMA PET/CT', 'orgStudyIdInfo': {'id': 'XH-17-020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with initial diagnosis of PCa', 'description': '1. T2 stage: PSA\\>20ng/ml, Gleason Score \\>= 8;\n2. T3 or T4 stage;\n3. The imaging examination was negative or localized metastasis of the pelvic lymph node, but there was no distant metastasis of lymph nodes or bone and internal organs other than the pelvic cavity.'}, {'label': 'Patients with biochemical recurrent PCa', 'description': '1. After the RRP surgery,the serum PSA was over 0.2 ng/ml in two consecutive sera;\n2. After the radiotherapy: the lowest PSA is up to 2 ng/ml.'}, {'label': 'Patients with CRPC', 'description': '1. The serum testosterone is in the castration level (\\< 50 ng/dL or \\< 1.7 nmol/L);\n2. The PSA is elevated 3 times in a row, the base value is increased by more than 50%, and the PSA \\> 2ng/mL(the interval is one week);\n3. The continuation of the anti-androgen drugs, flunamine was stopped for at least 4 weeks, and biglumide was suspended for at least 6 weeks;\n4. Despite the continued standard androgen deprivation therapy, the PSA is still progressing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hui Wang, MD', 'role': 'CONTACT', 'email': 'wanghuishanghai@hotmail.com', 'phone': '+86-021-25076980'}, {'name': 'Jun Qi, MD', 'role': 'CONTACT', 'email': 'qijun@xinhuamed.com.cn', 'phone': '+86-021-25078080'}], 'overallOfficials': [{'name': 'Hongliang Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}