Table 1.
Ongoing Phase II and III clinical trials of PSMA-based imaging with enrolment of at least 100 participants.
| Radioligand | Clinical Trial Identifier | Study Title | Phase | Primary Study Objective |
|---|---|---|---|---|
| 68Ga-PSMA-11 | NCT03362359 | 68Ga-PSMA-11 in High-risk Prostate Cancer | I/II | Assess safety and diagnostic performance of 68Ga-PSMA-11 PET/CT in patients with newly diagnosed high-risk PCa. |
| NCT03439033 | Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men with Prostate Cancer | II | Compare diagnostic performance of 68Ga-PSMA-HBED-CC PET/CT and PET/MRI vs. MRI alone for primary Pca or BRCP. | |
| NCT04050215 | 68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients with Prostate Cancer | II | Evaluate impact of 68Ga-PSMA-11 PET/CT on treatment strategy for BRPC. | |
| NCT03204123 | PSMA PET Imaging of Recurrent Prostate Cancer | II | Evaluate diagnostic efficacy of 68Ga-HBED-CC-PSMA in BRPC. | |
| NCT03396874 | 68Ga-PSMA-11 PET in Patients with Biochemical Recurrence | II | Evaluate diagnostic performance of 68Ga-PSMA-11 PET/CT in BRPC. | |
| NCT03768349 | 68Ga-PSMA-11 and C-11 Choline PET in Patients with Biochemical Recurrence of Prostate Cancer | II | Evaluate diagnostic efficacy of 68Ga-PSMA-11 and C-11 Choline PET in metastatic PCa. | |
| NCT03689582 | Radiolabeled 68Ga-PSMA for PET/CT Imaging to Detect Prostate Cancer | II | Evaluate diagnostic efficacy of 68Ga-PSMA-11 for the detection of primary PCa. | |
| NCT03762759 | Fluciclovine F18 or 68Ga-PSMA PET/CT to Enhance Prostate Cancer Outcomes | II | Compare efficacy of Fluciclovine F18 or 68Ga--PSMA PET/CT in planning radiation treatments and enhancing outcomes in patients with PCa. | |
| NCT03822845 | Evaluating the Clinical Accuracy of 68Ga-PSMA PET/CT Imaging in Patients with Biochemical Recurrence of Prostate Cancer | II/III | Evaluate diagnostic performance of 68Ga-PSMA PET/CT in BRPC. | |
| NCT02678351 | 68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients with Intermediate or High-Risk Prostate Cancer Undergoing Surgery | II/III | Evaluate diagnostic performance of 68Ga-PSMA PET/MRI for detection of regional nodal and distant metastases in patients with intermediate- and high-risk PCa. | |
| NCT03001869 | 68Ga-PSMA PET/CT in Prostate Cancer | III | Determine safety, sensitivity, and specificity of 68Ga-PSMA PET/CT for BRPC. | |
| NCT02659527 | PET/MRI in Patients With Suspected Prostate Cancer | III | Evaluate superiority of image guided biopsy using PSMA-PET/MRI in the diagnosis of primary PCa compared to conventional biopsy. | |
| NCT03582774 | Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning (PSMA-SRT) | III | Evaluate the success rate of salvage radiation therapy (SRT) for recurrence of PCa after prostatectomy with and without planning based on 68Ga-PSMA-11 PET/CT. | |
| NCT03803475 | 68Ga-PSMA-11 PET Imaging in Prostate Cancer Patients | III | Evaluate diagnostic performance of 68Ga-PSMA-11 in detection of metastatic PCa. | |
| NCT03353740 | 68Ga-PSMA-11 Positron Emission Tomography (PET) Imaging in Patients with Biochemical Recurrence | III | Evaluate diagnostic performance of 68Ga-PSMA-11 in detection of BRPC. | |
| NCT03911310 | 18F-PSMA-11 PET/CT Phase 3 Clinical Study (NGP3) | III | Compare diagnostic performance of 18F-PSMA-11 and 68Ga-PSMA-11. | |
| 18F-DCFPyL | NCT03181867 | 18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer | II | Assess the ability of 18F-DCFPyL PET/CT to accurately stage high-risk primary PCa and detect sites of recurrent PCa. |
| NCT03976843 | Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer | Evaluate efficacy of 18F-DCFPyL in predicting recurrence of PCa in high-risk PCa prior to prostatectomy. | ||
| NCT03471650 | Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer | II | Evaluate diagnostic accuracy of 18F-DCFPyL PET/CT for detecting primary PCa. |
|
| NCT03824275 | 18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer | II/III | Evaluate the efficacy of 18F-DCFPyL PET/CT as a predictive biomarker of response to therapy. | |
| NCT03525288 | PSMA-PET Guided Radiotherapy (PSMA-PETgRT) | II/III | Compare cancer control outcomes of definitive radiotherapy informed by PSMA-PET with radiotherapy guided by conventional staging only. | |
| NCT03594760 | PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer | III | Acquire PSMA-PET data in patients with PCa who receive treatment and follow-up in order to enable the discovery of predictive imaging biomarkers through deep learning techniques. | |
| NCT03739684 | Study of 18F-DCFPyL PET/CT Imaging in Patients with Suspected Recurrence of Prostate Cancer (CONDOR) | III | Evaluate diagnostic performance of 18F-DCFPyL PET/CT in patients with suspected BRPC and negative or equivocal findings on conventional imaging. | |
| 18F-PSMA-1007 | NCT04102553 | 18F-PSMA-1007 Versus F-18-Fluorocholine PET in Patients with Biochemical Recurrence | III | Compare diagnostic performance of 18F-PSMA-1007 Versus F-18-Fluorocholine PET in patients with BRPC. |
| rhPSMA 7.3 (18F) | NCT04186819 | Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE) | III | Evaluate safety and diagnostic performance of radio-hybrid prostate-specific membrane antigen (rhPSMA) 7.3 (18F) PET ligand in men with newly diagnosed prostate cancer. |
| NCT04186845 | Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT) | III | Evaluate safety and diagnostic performance of radio-hybrid prostate-specific membrane antigen (rhPSMA) 7.3 (18F) in BRPC. |