Table 3.
Summary of the ongoing clinical trials with PSMA PET/CT for the initial detection of PCa (source: https://clinicaltrials.gov/), accessed up to 28 February 2022.
| Trial Identifier Number | Phase | Status | Radiotracer | AIM | Country |
|---|---|---|---|---|---|
| NCT05154162 | III | Recruiting | Not specified | To evaluate PSMA PET/CT additive value for sPCa diagnosis in men with negative/equivocal MRI | Australia |
| NCT02282137 | II | Recruiting | [68Ga]PSMA-11 | Sensitivity of PSMA PET/CT for the detection of tumor location | USA |
| NCT04179968 | NA | Recruiting | [68Ga]PSMA-11 | To assess the ability of PSMA PET/CT to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated PI-RADS scores and PSA | USA |
| NCT05002465 | NA | Available | [68Ga]PSMA-11 | To provide PSMA PET/CT for clinical use in the diagnosis, staging, and restaging | USA |
| NCT05297162 | NA | Recruiting | [68Ga]PSMA-11 | To compare PSMA PET/TRUS vs. mpMRI/TRUS fusion prostate biopsy in men with a high suspicion of PCa after at least one negative biopsy | Italy |
| NCT05160597 | I | Recruiting | [68Ga]PSMA-11 | To identify prostate cancer in men with a prior negative or inconclusive prostate biopsy | USA |
| NCT05137561 | NA | Recruiting | [68Ga]PSMA | To compare the diagnostic yield of robotic-arm-assisted PSMA PET/CT–guided prostate biopsy and MRI-directed TRUS-guided prostate biopsy in patients with PI-RADS grading of 4/5 | India |
| NCT04867603 | III | Recruiting | [68Ga]PSMA | Diagnostic performance of digital PET/CT using 68Ga PSMA for the characterization of prostate lesions | USA |
Abbreviations: mpMRI, multiparametric magnetic resonance imaging; NA, not available; PI-RADS, prostate imaging reporting and data system; PSA, prostate-specific antigen; PSMA PET/CT, prostate-specific membrane antigen positron emission tomography/computed tomography; sPCa, significant prostate cancer; TRUS, transrectal ultrasonography-guided biopsy.