68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks (UROPET)

May 11, 2026 updated by: University Hospital, Bordeaux

Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Prostate Cancer of Various Metastatic Risks Candidates for Radical Prostatectomy - "UROPET"

Patients with primary prostate cancer (low, intermediate or high metastatic risk) 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 15% of men with prostate cancer have high-risk disease at diagnosis. For these patients the accuracy of initial staging is of critical importance for treatment decision-making.

Recommended imaging modalities for initial staging include computerized tomography (CT) scan, bone scan, and Magnetic Resonance Imaging (MRI). In addition to initial work-up, 18F-Choline Positron Emission Tomography coupled with scanner (PET-CT) may be proposed in some high-risk patients but its sensitivity for lymph node detection remains limited.

Nowadays, new radiotracers are becoming available for prostate cancer imaging. Among them, PET-CT imaging with radiolabeled ligands of prostate specific membrane antigen (PSMA) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as it is the case with radiolabeled PSMA-617 which has demonstrated very promising results in men with metastatic prostate cancer in recent studies.

Therefore, PET imaging with 68Ga-PSMA-617 may participate to optimize work-up in the staging of high-risk patients.

Another family of radiopharmaceuticals aimed to target the Gastrin-Releasing Peptide Receptor (GRP-R) which is overexpressed in low-grade prostatic carcinomas. GRP-R expression is correlated with androgen receptor expression and with better outcomes.

Various radiolabeled GRP analogues have been developed and one of them, 68Ga-RM2, has shown very promising preclinical results. A study in 14 patients with prostate cancer showed encouraging results as related to the detection of primary prostate cancer and metastatic lymph nodes as well as in detection of local recurrence in the prostate bed and nodal relapse. However, 68Ga-RM2 failed to show some bone metastases in hormone-refractory patients. 68Ga-RM2 has also been recently used and compared to 68Ga-PSMA-11 for targeting biochemically recurrent prostate cancer. These radiotracers may offer complementary performances in lymph nodes detection due to their distinct pharmacokinetics.

Since 68Ga-RM2 and 68Ga-PSMA-617 target different cell populations, combining these two radiopharmaceuticals in patients could be of additional value.

The aim of this pilot study is to compare 68Ga-PSMA-617 PET/CT to 68Ga-RM2 PET/CT in 24 patients with prostate cancer of various progression risks to better understand how they could performed a metastatic risk mapping and how they could be used (or combined) in clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Bordeaux University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria :

24 patients divided in :

  • 6 patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value < 10 ng/mL)
  • 12 patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL) divided in : 6 patients who are Gleason score 7(3+4) (favourable intermediate risk) 6 patients who are Gleason score 7(4+3) (unfavourable intermediate risk)
  • 6 patients with high risk prostate cancer (Gleason > 7 or cT2c or PSA value > 20 ng/mL)
  • Candidate for radical prostatectomy after discussion in multidisciplinary committee
  • Covered by the national health insurance system
  • Written informed consent willingly obtained

Exclusion criteria :

  • any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);
  • patient not candidate for radical prostatectomy and/or unable to benefit from surgery
  • freedom deprivated patient by judiciary or administrative decision
  • patient under legal protection or unable to express its own consent
  • patient within exclusion period from another clinical trial
  • known contraindication to radiopharmaceuticals and / or excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Median Standardized Uptake Value (SUV)
Time Frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617
Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Median Standardized Uptake Value (SUV)
Time Frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Median Standardized Uptake Value (SUV) of 68Ga-RM2
Day 0 (inclusion) or Day 2 to 21 (Visit 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Gleason score
Time Frame: Day 3 to 60 (Last visit)
Day 3 to 60 (Last visit)
Receptor density Bmax
Time Frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Local radioactive concentration (cpm)
Time Frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Immunoreactive score (IRS)
Time Frame: Day 3 to 60 (Last visit)
Day 3 to 60 (Last visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: CLERMONT-GALLERANDE Henri, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2016/38
  • 2017-000490-36 (EudraCT Number)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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