Clinical trial · Interventional
PET/MRI to Stage Prostate Cancer Patients
Phase II Monocentric Study to Evaluate a Novel Approach for Staging Prostate Cancer Patients by Using a Fully Integrated Hybrid PET/MRI
- 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)
The main goal of this phase II clinical trial is to define a novel approach of staging prostate cancer (PCa) patients by using a fully integrated positron emission tomography/ magnetic resonance imaging (PET/MRI) system with 68Ga-prostate specifica membrane antigen (PSMA) and 68Ga-RM2 (bombesin antagonist). 50 patients with biopsy proven PCa will be studied by PET/MRI with 68Ga-PSMA and with 68Ga-RM2 and then will undergo prostatectomy and pelvic lymphadenectomy.
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 | Drug | — | UNRESOLVED |
| 68Ga-RM2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Dual tracer PET/MRI
- interventionNames
- Drug: 68Ga-PSMA
- Drug: 68Ga-RM2
Primary outcomes (1)
- measure
- To define the diagnostic accuracy of PET/MRI system with the novel tracers 68Ga-PSMA and 68Ga-RM2 for the localization of primary prostate cancer
- timeFrame
- baseline
- description
- All patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 and then imaging findings will be correlated to histopathological findings gathered after prostatectomy. Specifically, at the patient level, we will count the number of patients where the different imaging modalities identified at least one intraprostatic cancer lesion. At the lesion level, on the other hand, we will match the intraprostatic lesions identified at imaging with those detected at histopathological examination. Therefore, providing measures of sensitivity, specificity, PPV, NPV for each imaging modality investigated ( 68Ga-PSMA PET, 68Ga-RM2 PET and MRI) at the lesion level.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years-old * Biopsy proven high-grade PCa referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy. * Willing to provide a signed informed consent Exclusion Criteria: * Age \< 18 years-old * Inability to complete the needed imaging examinations (i.e. severe claustrophobia) * Any additional medical condition that may significantly interfere with study compliance * All the contraindications for MRI study (i.e. pacemaker) * Evidence of metastatic disease on conventional imaging contraindicating the surgical procedure
References
Publications (0)
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