Prostate Cancer
Conditions
Keywords
Prostate Cancer, 68Ga-RM2, 68Ga-Prostate Specific Membrane Antigen, PET/CT, Prostate cancer imaging
Brief summary
Patients with primary intermediate risk prostate cancer 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.
Detailed description
European Association of Urology (EAU) Guidelines for initial staging of intermediate risk prostate cancer (Gleason score 3+4 and 4+3) include tomodensitometry (CT scan), magnetic resonance imaging (MRI) and bone scintigraphy. However, this group of tumor is highly heterogeneous. A distinction exist between tumors with Gleason score 3+4 (lower risk) and 4+3 which may be closer to high risk prostate cancer. Consequently, management of these two sub-groups of tumors differs. The key point for optimal management of these tumors is to get specific and non-invasive molecular tools for better classification and stratification. This is of critical importance for personalized treatment decision-making. Novel innovative radiotracers are today available for prostate cancer imaging notably small molecules, radiolabeled with 68Ga, targeting the prostate specific membrane antigen (PSMA) or antagonists, radiolabeled with 68Ga, targeting the Gastrin-Releasing Peptide receptor (GRP-R, a bombesin receptor subtype). There are on growing evidences that Positron Emission Tomography coupled to Computed Tomography (PET-CT) with radiolabeled prostate specific membrane antigen analogues (PSMA) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as shown with PSMA-617 in recent studies.
Interventions
PET/CT Imaging with 68Ga-PSMA-617 injection
DRUG68Ga-RM2 PET/CT
PET/CT Imaging with 68Ga-RM2 injection
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
15 patients divided in : * 7 patients with favourable intermediate risk prostate cancer (cT2b or Gleason score 7 (3+4) or PSA value 10-20 ng/mL, Briganti 5-20%,) * 8 patients with unfavourable intermediate risk prostate cancer (cT2b or Gleason score 7 (4+3) or PSA value 10-20 ng/mL, Briganti 5-20%,) * who are candidate for radical prostatectomy after discussion in multidisciplinary committee * covered by the national health insurance system * with freely written informed consent obtained
Exclusion criteria
* Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…); * Patient with prostate cancer not candidate for radical prostatectomy and/or unable to benefit from surgery * Freedom privated patient * Patient under legal protection or unable to express its own consent * Known contraindication to radiopharmaceuticals and / or excipients ……
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Standardized Uptake Value (SUV) | Day 0 (inclusion) or Day 2 to 21 (Visit 2) | Uptake intensity of 68Ga-PSMA-617 |
Secondary
| Measure | Time frame |
|---|---|
| Gleason score | Day 3 to 60 (Last visit) |
| Receptor density Bmax | Day 0 (inclusion) or Day 2 to 21 (Visit 2) |
| Local radioactive concentration (cpm) | Day 0 (inclusion) or Day 2 to 21 (Visit 2) |
| Immunoreactive score (IRS) | Day 3 to 60 (Last visit) |
| New World Health Organization 2016 classification | Day 3 to 60 (Last visit) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHenri CLERMONT-GALLERANDE
University Hospital, Bordeaux
Outcome results
None listed