Prostate CancerPhase 2PROSTATEPNCT03606837
68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Intermediate Risk Prostate Cancer Imaging
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.
Trial 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… 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
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2019to 11 Jul 2023
- 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
- 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
Who cannot join
- 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 ……
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- 68Ga-PSMA-617 PET/CT, 68Ga-RM2 PET/CT
- Keywords
- Prostate Cancer, 68Ga-RM2, 68Ga-Prostate Specific Membrane Antigen, PET/CT, Prostate cancer imaging
- 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 group | Role | What they receive |
|---|---|---|
| PET/CT Imaging | Experimental | Not 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.
Median Standardized Uptake Value (SUV)
Uptake intensity of 68Ga-PSMA-617
Measured: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Secondary outcomes (5)
Gleason score
Measured: Day 3 to 60 (Last visit)
Receptor density Bmax
Measured: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Local radioactive concentration (cpm)
Measured: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Immunoreactive score (IRS)
Measured: Day 3 to 60 (Last visit)
New World Health Organization 2016 classification
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.
- First posted31 Jul 2018
- Study start11 Jul 2019
- Primary completion15 Jun 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri CLERMONT-GALLERANDE, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606837
- Sponsor's protocol ID
- CHUBX2016/46
- Other IDs
- 2017-000489-31, 2017
- Acronym
- PROSTATEP
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2018
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perozziello F, Robert G, Meyer M, Jambon E, Bladou F, Yacoub M, Lamare F, Vimont D, Balamoutoff N, Hindie E, Morgat C. Prospective head-to-head comparison of [68Ga]Ga-RM2 PET/CT and [68Ga]Ga-PSMA-617 PET/CT in newly diagnosed patients with intermediate-risk localized prostate cancer. Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4386-4394. doi: 10.1007/s00259-026-07780-y. Epub 2026 Feb 9.
PubMed 41656418
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03606837
- Acronym / sponsor ID
- PROSTATEP / CHUBX2016/46
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, 68Ga-RM2, 68Ga-Prostate Specific Membrane Antigen, PET/CT, Prostate cancer imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT Imaging | Experimental | Drug: 68Ga-PSMA-617 PET/CT, Drug: 68Ga-RM2 PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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 ……
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-PSMA-617 PET/CTPET/CT Imaging with 68Ga-PSMA-617 injection | Drug | PET/CT Imaging |
| 68Ga-RM2 PET/CTPET/CT Imaging with 68Ga-RM2 injection | Drug | PET/CT Imaging |
Primary outcome
Median Standardized Uptake Value (SUV)
Time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)
Uptake intensity of 68Ga-PSMA-617
5 secondary outcomes
Gleason score
Time frame: Day 3 to 60 (Last visit)
Receptor density Bmax
Time frame: 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)
Immunoreactive score (IRS)
Time frame: Day 3 to 60 (Last visit)
New World Health Organization 2016 classification
Time frame: Day 3 to 60 (Last visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Results publication: PubMed 41656418Perozziello F, Robert G, Meyer M, Jambon E, Bladou F, Yacoub M, Lamare F, Vimont D, Balamoutoff N, Hindie E, Morgat C. Prospective head-to-head comparison of [68Ga]Ga-RM2 PET/CT and [68Ga]Ga-PSMA-617 PET/CT in newly diagnosed patients with intermediate-risk localized prostate cancer. Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4386-4394. doi: 10.1007/s00259-026-07780-y. Epub 2026 Feb 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henri CLERMONT-GALLERANDE principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
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 6 inclusion and 5 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 30 Jul 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)). 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 NCT03606837, which also lists 1 linked publication.
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 30 Jul 2026.