Table 3 Active clinical trials evaluating NGI in patients with BCR.
From: Application of next-generation imaging in biochemically recurrent prostate cancer
Study Phase | Anticipated Enrollment | Primary Objective | Primary Outcome Measure(s) | Estimated Completion Date | Study Identifier |
|---|---|---|---|---|---|
1/2 | 60 | Assessment of performance of 68Ga-P16-093 in intermediate to high-risk patients with primary PCa or BCR | Sensitivity Proportion of patients with treatment change due to lesion detection | July 2022 | NCT03444844 |
3 | 217 | Diagnostic performance and safety of 18F-DCFPyL vs 18F-fluorocholine in patients with BCR post-RP | Per-patient detection rate of 18F-DCFPyL PET/CT vs. 18F-fluorocholine PET/CT across 10 weeks | February 2022 | NCT04734184 |
3 | 136 | Diagnostic performance and safety of 18F-PSMA-1007 PET/CT in patients with BCR | Region-level PPV; Patient-level CDR | August 2023 | NCT04742361 |
2 | 100 | Assessment of 18F-DCFPyL PET/CT to identify early oligometastatic PCa in patients with BCR | Detection rate and performance metrics of 18F-DCFPyL PET/CT | September 2023 | NCT03160794 |
3 | 190 | Assessment of the diagnostic performance of 18F-CTT1057 for detection and localization of PSMA-positive lesions in patients with PCa diagnosed with BCR post-RP or EBRT using CTS as reference 1:1 Random sequence: PET/CT imaging with 18F-CTT1057 followed by 68Ga-PSMA-11 or vice versa | CLR, defined as the proportion of regions containing ≥1 TP lesion PPV, defined as proportion of patients who have one true positive lesion | December 2023 | NCT04838613 |
Pilot [93] | 100 | Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 | Patient-level detection rate | December 2023 | NCT05079828 |
3 [94] | 193 | Evaluation of the success rate for EBRT for BCR post-RP with 68Ga-PSMA-11 vs. standard of care | Success rate of salvage EBRT defined as BPFS after initiation of EBRT | July 2024 | NCT03582774 |
2 | 196 | Evaluation of MDT + WPRT + ADT vs. MDT + ADT in patients with BCR and PSMA PET-detected nodal recurrence | MFS | April 2025 | NCT03569241 |
2/3 | 464 | Evaluation of systemic therapy + PET-directed local therapy vs. systemic therapy only in patients with BCR post RP or EBRT and 1–5 suspicious lesions | CRPC-free survival | December 2025 | NCT04787744 |
2 | 140 | Comparison of 68Ga-PSMA-11 and 18F-fluciclovine to inform radiotherapy decision-making in patients with detectable PSA post RP | DFS | December 2025 | NCT03762759 |
2/3 | 130 | Evaluation of the success rate for EBRT with 18F-DCFPyL 11 vs. standard of care in patients with BCR, localized high-risk PCa or OMPC on conventional imaging | FFS | April 2026 | NCT03525288 |
3 | 873 | Evaluation of MDT + 6-mo ADT + enzalutamide vs MDT + 1-mo ADT vs MDT alone in patients with BCR and positive PSMA PET/CT or PET/MRI for oligorecurrent disease | PMFS | April 2032 | NCT05352178 |
3 | 804 | Application of 18F-fluciclovine PET/CT in delivery of treatment to patients with BCR | PFS assessed up to 10 years | December 2032 | NCT04423211 |
