Prostate Cancer Clinical Trial
— UROPETOfficial title:
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"
Verified date | June 2020 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Positron 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.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 19, 2019 |
Est. primary completion date | December 19, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria : 24 patients divided in : - 6 patients with low risk prostate cancer (Gleason score = 6 and cT1-T2a and Prostate Specific Antigen (PSA) value < 10 ng/mL) - 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) - 6 patients with high risk prostate cancer (Gleason > 7 or cT2c or PSA value > 20 ng/mL) - Candidate for radical prostatectomy after discussion in multidisciplinary committee - Covered by the national health insurance system - Written informed consent willingly obtained Exclusion criteria : - any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…); - patient not candidate for radical prostatectomy and/or unable to benefit from surgery - freedom deprivated patient by judiciary or administrative decision - patient under legal protection or unable to express its own consent - patient within exclusion period from another clinical trial - known contraindication to radiopharmaceuticals and / or excipients |
Country | Name | City | State |
---|---|---|---|
France | Bordeaux University Hospital | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median Standardized Uptake Value (SUV) | Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617 | Day 0 (inclusion) or Day 2 to 21 (Visit 2) | |
Primary | Median Standardized Uptake Value (SUV) | Median Standardized Uptake Value (SUV) of 68Ga-RM2 | Day 0 (inclusion) or Day 2 to 21 (Visit 2) | |
Secondary | Gleason score | Day 3 to 60 (Last visit) | ||
Secondary | Receptor density Bmax | Day 0 (inclusion) or Day 2 to 21 (Visit 2) | ||
Secondary | Local radioactive concentration (cpm) | Day 0 (inclusion) or Day 2 to 21 (Visit 2) | ||
Secondary | Immunoreactive score (IRS) | Day 3 to 60 (Last visit) |
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