Bordeaux University Hospital
Bordeaux, 33079, France
NCT Number: NCT03606837
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.
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Notify Me18 year and older
Male
Interventional
Phase 2
Bordeaux, 33079, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
15 patients divided in :
Exclusion criteria
PET/CT Imaging with 68Ga-PSMA-617 injection
PET/CT Imaging with 68Ga-RM2 injection
Time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Uptake intensity of 68Ga-PSMA-617
Time frame: Day 3 to 60 (Last visit)
Time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Time frame: Day 3 to 60 (Last visit)
Time frame: Day 3 to 60 (Last visit)
University Hospital, Bordeaux
Other
Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Intermediate Risk Prostate Cancer Candidates for Radical Prostatectomy
Acronym: PROSTATEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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