Clinical trial · Interventional
68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Intermediate Risk Prostate Cancer Imaging
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
- 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 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.
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 (1)
- measure
- Median Standardized Uptake Value (SUV)
- timeFrame
- Day 0 (inclusion) or Day 2 to 21 (Visit 2)
- description
- Uptake intensity of 68Ga-PSMA-617
Secondary outcomes (5)
- measure
- Gleason score
- timeFrame
- Day 3 to 60 (Last visit)
- measure
- Receptor density Bmax
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 ……
References
Publications (1)
- RESULTPerozziello 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. PMID 41656418