PET/MRI to Stage Prostate Cancer Patients
NCT Number: NCT06484361
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: 68Ga-PSMA|DRUG: 68Ga-RM2
Sponsor: IRCCS San Raffaele
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2020-09-09
Completion Date: 2025-09-30
Locations: IRCCS Ospedale San Raffaele, Milan, 20132, Italy

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.

Primary Outcome Measures: 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, 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., baseline
Secondary Outcome Measures: To optimize PET/MRI with 68Ga-PSMA and 68Ga-RM2 protocol by using novel imaging technique to stage PCa patients., The image acquisition protocol will be adjusted to ensure high quality of the images and patient compliance (measured with the number of patients that will complete all study procedures), baseline|To characterize the primary PCa phenotype in high-grade patients, The correlation between Gleason Score and clinical data will be investigated with univariate and multivariate general linear models. Specifically, standardized uptake value (SUV)max and SUVmean of 68Ga-PSMA and 68Ga-DOTA-RM2, apparent diffusion coefficient (ADC)min and ADCmean, cellular markers in the peripheral blood, as well as radiomic features extracted from PET and mpMR images will be investigated., baseline|To evaluate the stability and reproducibility of imaging features in mp-MRI with test-retest procedure., Mann-whitney test will be used to assess the difference in the radiomic features extracted two days apart from the same MRI sequences, baseline|To evaluate the diagnostic accuracy of PET/MRI with 68Ga-PSMA and 68Ga-RM2 to stage T, N and M parameters in PCa patients., To assess PET/MRI diagnostic accuracy for PCa primary staging (N and M) with 68Ga-PSMA and 68Ga-RM2, PET/MRI whole body images will be evaluated by a Nuclear Medicine and Radiology expert physicians, being aware of the patients' medical history and results of other imaging modalities. Histological data will be used as gold standard for the evaluation of diagnostic accuracy when possible; conventional imaging/follow-up will be used for the confirmation of M parameter. In case of positive findings, a histologic confirmation will be obtained when technically feasible. In particular, pelvic and/or retroperitoneal lymph nodes dissection will be performed in all patients included in the study. A biopsy of the suspicious lesion would be considered when possible in patients with metastases located in other sites. The diagnostic accuracy for T, N and M parameters will be measured with sensitivity, specificity, PPV and NPV at the patient level., 24 months after baseline|To evaluate patient management based on PET/MRI studies., It will be assessed in how many cases the PET/MRI studies affected the well-being patients, measured with survival analysis, 24 months