Multi-cohort effectiveness of Gallium-68-PSMA PET/CT and pelvic 3Tesla multi-parametric magnetic resonance imaging in the diagnostic and therapeutic work-up of prostate cancer (MoH RF-2016-02364230)

The project "Multi-cohort effectiveness of Gallium-68-PSMA PET/CT and pelvic 3Tesla multi-parametric magnetic resonance imaging in the diagnostic and therapeutic work-up of prostate cancer" is funded by Italian Ministry of Health (project code: RF-2016-02364230)

Based on preliminary data, the project hypothesis was that diagnostic accuracy of 68Ga-PSMA PET/CT is comparable to that of mp-3TMRI in pts with pCa. If that is the case, the use of 68Ga-PSMA PET/CT will lead to shorter waiting lists, faster scanning time and lower costs compared to mp-3TMRI. The 1st goal of this project is to guide or replace invasive procedures with a non invasive approach such as mp-3TMRI or 68Ga-PSMA PET/CT. The secondary aim is a comparative analysis of the 2 techniques.  
Specific Aim 1:
Characterize the incremental benefit of pelvic mp-MRI and 68Ga-PSMA PET/CT in: guiding TRUS-B, to identify clinicallysignificant PCa in pts who are negative at first-round TRUS-B and/or are undergoing AS.
Stage accuracy of pelvic mp-MRI and 68Ga PSMA PET/CT during the pre-surgical work-up of high-risk PCa pts and PCa pts who are candidates for nerve-sparing surgery.
The secondary aim is a comparative analysis of the 2 techniques.
Specific Aim 2:
Evaluate the accurancy of 68Ga-PSMA PET/CT (i.e. Sensitivity, SE; specificity, SP) in detecting sites of biochemical PCa recurrence compared to routinely-used diagnostic tools (TRUS-B, bone scan, diagnostic CT, MRI and 18F-FCH PET/CT).
The secondary objectives are SE for different PSA values and SE for different Gleason score.
Specific Aim 3:
Evaluate the efficacy in terms of Disease Control Rate (DCR) and the safety of 2 different administration schedules of 177Lu-PSMA in a cohort (C) of metastatic CRPC pts previously treated with standard therapy.