Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 6:27 AM
Study NCT ID:
NCT06901492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2025-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-23', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biospy outcome', 'timeFrame': '12 months', 'description': 'Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.'}], 'secondaryOutcomes': [{'measure': 'Duration of puncture operation', 'timeFrame': '12 months', 'description': "Record the time required for each patient's puncture procedure"}, {'measure': "Patient's pain level", 'timeFrame': '12 months', 'description': 'Based on VAS pain score'}, {'measure': 'Blood loss', 'timeFrame': '12 months', 'description': 'Bleeding volume during and after operation'}, {'measure': 'Complication', 'timeFrame': '12 months', 'description': 'Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'PSMA PET/CT', 'mpMRI', 'Prostate biopsy'], 'conditions': ['PSMA PET/CT', 'Prostate Cancer', 'MpMRI']}, 'descriptionModule': {'briefSummary': 'The present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥40 years, male;\n2. Serum PSA level 4-20 ng/mL;\n3. Serum PSA level 4-20 ng/mL;\n4. No contraindications to PSMA-PET/CT or MRI;\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. Serum PSA \\>20 ng/mL;\n2. History of prostate surgery/radiotherapy;\n3. Acute prostatitis;\n4. Coagulation disorders or active infection;\n5. Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions;\n6. Allergy to local anesthetics;\n7. Inability to tolerate the biopsy procedure.'}, 'identificationModule': {'nctId': 'NCT06901492', 'briefTitle': 'The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy', 'orgStudyIdInfo': {'id': 'KY20250225-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET+/mpMRI+ group', 'description': 'Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.', 'interventionNames': ['Diagnostic Test: Prostate biopsy guided by PSMA PET/CT']}, {'type': 'EXPERIMENTAL', 'label': 'PET+/mpMRI- group', 'description': 'Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.', 'interventionNames': ['Diagnostic Test: Prostate biopsy guided by PSMA PET/CT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PET-/mpMRI+ group', 'description': 'Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on PSMA PET and positive on mpMRI. These patients will undergo prostate biopsy guided by mpMRI and US.', 'interventionNames': ['Diagnostic Test: Prostate biopsy guided by mpMRI/US']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PET-/mpMRI- group', 'description': 'Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on both PSMA PET and mpMRI. These patients will undergo systematic prostate biopsy.', 'interventionNames': ['Diagnostic Test: Systematic prostate biopsy']}], 'interventions': [{'name': 'Prostate biopsy guided by PSMA PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patient will undergo pelvic non-contrast CT imaging. After co-registration of the CT images with 68Ga-PSMA PET/CT data at corresponding anatomical levels, a percutaneous gluteal approach will be utilized for CT-guided prostate biopsy.', 'armGroupLabels': ['PET+/mpMRI+ group', 'PET+/mpMRI- group']}, {'name': 'Prostate biopsy guided by mpMRI/US', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patient will undergo transrectal ultrasound (TRUS) prostate scanning. After co-registration and precise image fusion of TRUS findings with multiparametric MRI (mpMRI) data, a transperineal percutaneous approach will be employed to perform TRUS-guided prostate biopsy.', 'armGroupLabels': ['PET-/mpMRI+ group']}, {'name': 'Systematic prostate biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patient will undergo systematic prostate biopsy under TRUS guidance.', 'armGroupLabels': ['PET-/mpMRI- group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Hongbin Sun, MD, PHD', 'role': 'CONTACT', 'email': 'docshb@126.com', 'phone': '+86-02552271061'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hongbin Sun Sun, MD, PHD', 'role': 'CONTACT', 'email': 'docshb@126.com', 'phone': '+86-02552271061'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}