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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000489-31 | EudraCT Number |
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target number of patients not reached
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT Imaging | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-PSMA-617 PET/CT | Drug | PET/CT Imaging with 68Ga-PSMA-617 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median Standardized Uptake Value (SUV) | Uptake intensity of 68Ga-PSMA-617 | Day 0 (inclusion) or Day 2 to 21 (Visit 2) |
| Measure | Description | 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) |
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Inclusion criteria:
15 patients divided in :
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri CLERMONT-GALLERANDE | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | 33079 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41656418 | Derived | Perozziello F, Robert G, Meyer M, Jambon E, Bladou F, Yacoub M, Lamare F, Vimont D, Balamoutoff N, Hindie E, Morgat C. Prospective head-to-head comparison of [68Ga]Ga-RM2 PET/CT and [68Ga]Ga-PSMA-617 PET/CT in newly diagnosed patients with intermediate-risk localized prostate cancer. Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4386-4394. doi: 10.1007/s00259-026-07780-y. Epub 2026 Feb 9. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 68Ga-RM2 PET/CT |
| Drug |
PET/CT Imaging with 68Ga-RM2 injection |
|
| 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) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |