PET/MRI to Stage Prostate Cancer Patients
NCT06484361 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-07-03
Summary
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
Interventions
- DRUG
-
68Ga-PSMA
all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention
- DRUG
-
68Ga-RM2
all patients will undergo PET/MRI with 68Ga-PSMA and 68Ga-RM2 prior to surgical intervention
Sponsors & Collaborators
-
IRCCS San Raffaele
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-09
- Primary Completion
- 2025-09-30
- Completion
- 2025-09-30
Countries
- Italy
Study Locations
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