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

NCT ID: NCT03606837

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2023-07-11

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PET/CT Imaging

Group Type: EXPERIMENTAL

68Ga-PSMA-617 PET/CT

Intervention Type: DRUG

PET/CT Imaging with 68Ga-PSMA-617 injection

68Ga-RM2 PET/CT

Intervention Type: DRUG

PET/CT Imaging with 68Ga-RM2 injection

Interventions

68Ga-PSMA-617 PET/CT

PET/CT Imaging with 68Ga-PSMA-617 injection

Intervention Type: DRUG

68Ga-RM2 PET/CT

PET/CT Imaging with 68Ga-RM2 injection

Intervention Type: DRUG

Eligibility Criteria

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 ……

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henri CLERMONT-GALLERANDE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Bordeaux University Hospital

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX2016/46

Identifier Type: -

Identifier Source: org_study_id