Clinical trial · Interventional
68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks
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"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-617 PET/CT | Drug | — | UNRESOLVED |
| 68Ga-RM2 PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT Imaging
- interventionNames
- Drug: 68Ga-PSMA-617 PET/CT
- Drug: 68Ga-RM2 PET/CT
Primary outcomes (2)
- measure
- Median Standardized Uptake Value (SUV)
- timeFrame
- Day 0 (inclusion) or Day 2 to 21 (Visit 2)
- description
- Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617
- measure
- Median Standardized Uptake Value (SUV)
- timeFrame
- Day 0 (inclusion) or Day 2 to 21 (Visit 2)
- description
- Median Standardized Uptake Value (SUV) of 68Ga-RM2
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTSchollhammer 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. PMID 36215569
- RESULTSchollhammer 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. PMID 37190273