Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT05596851
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2022-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, specificity and positive predictive value in a per-region analysis', 'timeFrame': 'March 2022 - March 2023'}], 'secondaryOutcomes': [{'measure': 'Comparison of β-probe intra-operatory measurements with ex-vivo ones.', 'timeFrame': 'March 2022 - March 2023'}, {'measure': 'Comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters', 'timeFrame': 'March 2022 - March 2023', 'description': 'SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters'}, {'measure': 'Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC).', 'timeFrame': 'May 2022 - December 2023', 'description': 'IHC will be evaluated by PSMA staining on the surgical specimens.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PSMA', 'Radio-Guided Surgery', 'Radio Guided Surgery', 'Lymph Node Dissection', 'Prostate Cancer', 'PET', 'Positron Emission Tomography'], 'conditions': ['Prostate Cancer', 'Positron Emission Tomography', 'PSMA']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ieo.it/it/CHI-SIAMO/Come-siamo-organizzati/Le-divisioni/Divisione-di-Medicina-Nucleare-MNUDV/', 'label': 'IEO Nuclear Medicine'}, {'url': 'https://www.ieo.it/it/CHI-SIAMO/Come-siamo-organizzati/Le-divisioni/Divisione-di-Urologia-URODV/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.', 'detailedDescription': 'Study Phase: Phase II\n\nPrimary Objective:\n\nTo evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity.\n\nSecondary Objectives:\n\n* the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor.\n* safety and toxicity analysis regarding the intraoperative application of the β-probe.\n* the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images.\n* the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens\n\nDrug Dosage, Formulation, Administration: Intravenous administration of 1.1 MBq/Kg of 68Ga-PSMA-11.\n\nPrimary Endpoint: Primary: sensitivity and specificity in a per-region analysis.\n\nSecondary Endpoints:\n\n* comparison of β-probe intra-operatory measurements with ex-vivo ones.\n* comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters (SUVmax and PSMA-TV).\n* comparison of β-probe measurements and PSMA expression assessed by IHC (PSMA staining).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Biopsy proven high-risk prostate cancer patients, who performed PSMA PET/CT per clinical routine practice will be considered suitable for enrollment in case of pelvic nodal involvement detected at PSMA PET/CT. Patients affected by metastatic prostate cancer (any M) will be considered not eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven prostate cancer\n* High-risk prostate cancer (T\\>T2c and/or PSA\\>20 and/or ISUP\\>3)\n* Patients suitable for radical prostatectomy + pelvic lymph node dissection\n* 68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery\n* PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT\n* Age \\>18 years old\n* Willing to sign informed consent\n\nExclusion Criteria:\n\n* Patient unfit for surgery\n* M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation\n* Unable to tolerate PET scan'}, 'identificationModule': {'nctId': 'NCT05596851', 'briefTitle': 'Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.', 'orgStudyIdInfo': {'id': 'IEO 1703'}}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Ceci, MD PhD', 'role': 'CONTACT'}, {'name': 'Gennaro Musi, MD', 'role': 'CONTACT'}], 'facility': 'IEO European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Francesco Ceci, MD', 'role': 'CONTACT', 'email': 'francesco.ceci@ieo.it', 'phone': '+39 02-57489 315'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}