Detection Rate of 18F-rhPSMA-7.3 PET in Patients with Suspected Prostate Cancer Recurrence at PSA Levels

Abstract

Novel molecular imaging agents yield potential for localization of disease in patients with biochemical recurrence of prostate cancer when PSA levels are still low, and may facilitate early intervention with selective therapy to optimize outcomes. Radiohybrid (rh) positron emission tomography (PET) radiopharmaceutical, 18F-rhPSMA-7.3, is a novel high affinity prostate-specific membrane antigen (PSMA)-targeting ligand with potential for low bladder activity. The SPOTLIGHT study (NCT04186845) evaluated the diagnostic performance of 18F-rhPSMA-7.3 in men with suspected prostate cancer recurrence. Here, we report findings from a post-hoc analysis of SPOTLIGHT data, which determined the 18F-rhPSMA-7.3 detection rates (DR) at low-very low PSA levels. Patients enrolled in SPOTLIGHT underwent PET 50-70 min after IV administration of 296 MBq 18F-rhPSMA-7.3. Scans were evaluated by 3 blinded central readers, with the majority read representing agreement between ≥2 independent readers. For the present analysis, all patients with an evaluable 18F-rhPSMA-7.3 PET and who had a baseline PSA <1 ng/mL were selected. Overall (patient-level) and regional DR by majority read were determined, stratifying DR according to the patients' baseline PSA level (<0.2, ≥0.2 - <0.3, ≥0.3 - <0.5, and ≥0.5 - <1 ng/mL). In total, 389 patients (median [range] PSA, 1.10 [0.03-135] ng/mL, 84 with intact prostate) had an evaluable 18F-rhPSMA-7.3 scan. The overall DR was 83% (322/389) by majority read. Of the 389 patients with an evaluable 18F-rhPSMA-7.3 scan, 188 had a baseline PSA <1 ng/mL and were eligible for the present analysis. Despite low patient numbers in some PSA categories, moderate to high DR were observed, with the patient-level DR shown to increase with increasing baseline PSA (see table). Overall, 68% (128/188) of patients with a PSA <1 ng/mL and 64% (77/121) of patients with a PSA <0.5 ng/mL had a positive 18F-rhPSMA-7.3 scan by majority read. Regional DR were broadly consistent across all PSA categories. Of note, extrapelvic lesions were observed in 21% (25/121) of patients with a PSA <0.5 ng/mL and 27% (51/188) of all patients with a PSA <1 ng/mL. Among this cohort of patients with low-very low PSA levels, more than two-thirds were found to have positive 18F-rhPSMA-7.3 scans. Of clinical significance, over a quarter of patients had extrapelvic findings. 18F-rhPSMA-7.3 PET may be a useful tool for treatment planning in patients with early biochemical recurrence of prostate cancer where curative salvage therapy is of prime consideration.