68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Intermediate Risk Prostate Cancer Imaging

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: 68Ga-PSMA-617 PET/CT; Drug: 68Ga-RM2 PET/CT

• Registration Number: NCT03606837
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-31
• Study Start: 2019-07-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19
• Primary Completion: 2023-08-17
• Study Completion: 2023-08-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT Imaging	68Ga-PSMA-617 PET/CT	-
PET/CT Imaging	68Ga-RM2 PET/CT	-

Primary Outcome Measures

Name	Time	Method
Median Standardized Uptake Value (SUV)	Day 0 (inclusion) or Day 2 to 21 (Visit 2)	Uptake intensity of 68Ga-PSMA-617

Secondary Outcome Measures

Name	Time	Method
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)
Gleason score	Day 3 to 60 (Last visit)
New World Health Organization 2016 classification	Day 3 to 60 (Last visit)

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France