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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 68Ga-PSMA-617 PET/CT; Drug: 68Ga-RM2 PET/CT

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Henri CLERMONT-GALLERANDE; Phone Number: 05 56 79 55 40; Email: henri.de-clermont-galleran@chu-bordeaux.fr
• Study Contact Backup: Name: Clément MORGAT; Phone Number: 05 56 79 55 40; Email: clement.morgat@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33079
    • Recruiting
    • Bordeaux university hospital
    • Contact: Henri DE CLERMONT-GALLERANDE; Phone Number: 05 56 79 55 40; Email: henri.de-clermont-galleran@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 ……

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/CT Imaging	Drug: 68Ga-PSMA-617 PET/CT; PET/CT Imaging with 68Ga-PSMA-617 injection; Drug: 68Ga-RM2 PET/CT; PET/CT Imaging with 68Ga-RM2 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Henri CLERMONT-GALLERANDE, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Anticipated): August 17, 2023
• Study Completion (Anticipated): August 17, 2023

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: PET/CT; Prostate Cancer; 68Ga-RM2; 68Ga-Prostate Specific Membrane Antigen; Prostate cancer imaging
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: CHUBX2016/46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No