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Prostate CancerPhase 2UROPETNCT03604757

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

A Phase 2 study testing 68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT in people with Prostate Cancer, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteFrance
Study dates
25 Apr 2018to 19 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Bordeaux University Hospital

    Bordeaux, 33076

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
68Ga-PSMA-617 PET/CT, 68Ga-RM2 PET/CT
Keywords
Prostate Cancer, 68Ga-RM2, bombesin, GRP-R, 68Ga-Prostate Specific Membrane Antigen, PSMA, PET/CT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-PSMA-617 PET/CTDrug

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

  • 68Ga-RM2 PET/CTDrug

    PET/CT Imaging with 68Ga-RM2 injection

Study groups in NCT03604757
Study groupRoleWhat they receive
PET/CT ImagingExperimentalNot described
Receives: Drug: 68Ga-PSMA-617 PET/CT; Drug: 68Ga-RM2 PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Standardized Uptake Value (SUV)

    Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617

    Measured: Day 0 (inclusion) or Day 2 to 21 (Visit 2)

  2. Median Standardized Uptake Value (SUV)

    Median Standardized Uptake Value (SUV) of 68Ga-RM2

    Measured: Day 0 (inclusion) or Day 2 to 21 (Visit 2)

Secondary outcomes (4)

  1. Gleason score

    Measured: Day 3 to 60 (Last visit)

  2. Receptor density Bmax

    Measured: Day 0 (inclusion) or Day 2 to 21 (Visit 2)

  3. Local radioactive concentration (cpm)

    Measured: Day 0 (inclusion) or Day 2 to 21 (Visit 2)

  4. Immunoreactive score (IRS)

    Measured: Day 3 to 60 (Last visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start25 Apr 2018
  3. Primary completion19 Dec 2019
  4. Study completion19 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03604757
Sponsor's protocol ID
CHUBX 2016/38
Other IDs
2017-000490-36, 2017
Acronym
UROPET
Status last verified
Jun 2020
First submitted
19 Jul 2018
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schollhammer R, Robert G, Asselineau J, Yacoub M, Vimont D, Balamoutoff N, Bladou F, Benard A, Hindie E, Gallerande HC, Morgat C. Comparison of 68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT in Patients with Localized Prostate Cancer Who Are Candidates for Radical Prostatectomy: A Prospective, Single-Arm, Single-Center, Phase II Study. J Nucl Med. 2023 Mar;64(3):379-385. doi: 10.2967/jnumed.122.263889. Epub 2022 Sep 2.

    PubMed 36215569

  • Schollhammer R, Quintyn Ranty ML, de Clermont Gallerande H, Cavelier F, Valverde IE, Vimont D, Hindie E, Morgat C. Theranostics of Primary Prostate Cancer: Beyond PSMA and GRP-R. Cancers (Basel). 2023 Apr 18;15(8):2345. doi: 10.3390/cancers15082345.

    PubMed 37190273

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT in people with Prostate Cancer, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Standardized Uptake Value (SUV) (time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03604757, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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UROPET Clinical Trial NCT03604757 | AzTrials