Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT03604757
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2018-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Standardized Uptake Value (SUV)', 'timeFrame': 'Day 0 (inclusion) or Day 2 to 21 (Visit 2)', 'description': 'Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617'}, {'measure': 'Median Standardized Uptake Value (SUV)', 'timeFrame': 'Day 0 (inclusion) or Day 2 to 21 (Visit 2)', 'description': 'Median Standardized Uptake Value (SUV) of 68Ga-RM2'}], 'secondaryOutcomes': [{'measure': 'Gleason score', 'timeFrame': 'Day 3 to 60 (Last visit)'}, {'measure': 'Receptor density Bmax', 'timeFrame': 'Day 0 (inclusion) or Day 2 to 21 (Visit 2)'}, {'measure': 'Local radioactive concentration (cpm)', 'timeFrame': 'Day 0 (inclusion) or Day 2 to 21 (Visit 2)'}, {'measure': 'Immunoreactive score (IRS)', 'timeFrame': 'Day 3 to 60 (Last visit)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', '68Ga-RM2', 'bombesin', 'GRP-R', '68Ga-Prostate Specific Membrane Antigen', 'PSMA', 'PET/CT'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with primary prostate cancer (low, intermediate or high metastatic risk) for whom radical prostatectomy is indicated, will be invited to participate to the present study.\n\nPositron Emission Tomography coupled with scanner (PET-CT) using a radiotracer : 68Ga-RM2 and Positron Emission Tomography coupled with scanner (PET-CT) using another radiotracer : 68Ga-PSMA-617, will be scheduled.', 'detailedDescription': 'Approximately 15% of men with prostate cancer have high-risk disease at diagnosis. For these patients the accuracy of initial staging is of critical importance for treatment decision-making.\n\nRecommended imaging modalities for initial staging include computerized tomography (CT) scan, bone scan, and Magnetic Resonance Imaging (MRI). In addition to initial work-up, 18F-Choline Positron Emission Tomography coupled with scanner (PET-CT) may be proposed in some high-risk patients but its sensitivity for lymph node detection remains limited.\n\nNowadays, new radiotracers are becoming available for prostate cancer imaging. Among them, PET-CT imaging with radiolabeled ligands of prostate specific membrane antigen (PSMA) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as it is the case with radiolabeled PSMA-617 which has demonstrated very promising results in men with metastatic prostate cancer in recent studies.\n\nTherefore, PET imaging with 68Ga-PSMA-617 may participate to optimize work-up in the staging of high-risk patients.\n\nAnother family of radiopharmaceuticals aimed to target the Gastrin-Releasing Peptide Receptor (GRP-R) which is overexpressed in low-grade prostatic carcinomas. GRP-R expression is correlated with androgen receptor expression and with better outcomes.\n\nVarious radiolabeled GRP analogues have been developed and one of them, 68Ga-RM2, has shown very promising preclinical results. A study in 14 patients with prostate cancer showed encouraging results as related to the detection of primary prostate cancer and metastatic lymph nodes as well as in detection of local recurrence in the prostate bed and nodal relapse. However, 68Ga-RM2 failed to show some bone metastases in hormone-refractory patients. 68Ga-RM2 has also been recently used and compared to 68Ga-PSMA-11 for targeting biochemically recurrent prostate cancer. These radiotracers may offer complementary performances in lymph nodes detection due to their distinct pharmacokinetics.\n\nSince 68Ga-RM2 and 68Ga-PSMA-617 target different cell populations, combining these two radiopharmaceuticals in patients could be of additional value.\n\nThe aim of this pilot study is to compare 68Ga-PSMA-617 PET/CT to 68Ga-RM2 PET/CT in 24 patients with prostate cancer of various progression risks to better understand how they could performed a metastatic risk mapping and how they could be used (or combined) in clinical practice.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n24 patients divided in :\n\n* 6 patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value \\< 10 ng/mL)\n* 12 patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL) divided in : 6 patients who are Gleason score 7(3+4) (favourable intermediate risk) 6 patients who are Gleason score 7(4+3) (unfavourable intermediate risk)\n* 6 patients with high risk prostate cancer (Gleason \\> 7 or cT2c or PSA value \\> 20 ng/mL)\n* Candidate for radical prostatectomy after discussion in multidisciplinary committee\n* Covered by the national health insurance system\n* Written informed consent willingly obtained\n\nExclusion criteria :\n\n* any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);\n* patient not candidate for radical prostatectomy and/or unable to benefit from surgery\n* freedom deprivated patient by judiciary or administrative decision\n* patient under legal protection or unable to express its own consent\n* patient within exclusion period from another clinical trial\n* known contraindication to radiopharmaceuticals and / or excipients'}, 'identificationModule': {'nctId': 'NCT03604757', 'acronym': 'UROPET', 'briefTitle': '68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Prostate Cancer of Various Metastatic Risks Candidates for Radical Prostatectomy - "UROPET"', 'orgStudyIdInfo': {'id': 'CHUBX 2016/38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET/CT Imaging', 'interventionNames': ['Drug: 68Ga-PSMA-617 PET/CT', 'Drug: 68Ga-RM2 PET/CT']}], 'interventions': [{'name': '68Ga-PSMA-617 PET/CT', 'type': 'DRUG', 'description': 'PET/CT Imaging with 68Ga-PSMA-617 injection', 'armGroupLabels': ['PET/CT Imaging']}, {'name': '68Ga-RM2 PET/CT', 'type': 'DRUG', 'description': 'PET/CT Imaging with 68Ga-RM2 injection', 'armGroupLabels': ['PET/CT Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'CLERMONT-GALLERANDE Henri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}