{"entity":{"id":"spotlight","kind":"trial","name":"SPOTLIGHT","aka":["18F-rhPSMA-7.3 biochemical recurrence trial"],"tldr":"A PET scan (the tracer later approved as Posluma) was tested in men whose PSA rose again after treatment for prostate cancer, to see how often it can find exactly where the cancer has come back.","summary":"SPOTLIGHT was a phase 3, prospective, multicentre, open-label, single-arm imaging trial of 18F-rhPSMA-7.3 (flotufolastat F-18, brand Posluma) in men with biochemically recurrent prostate cancer being considered for salvage therapy. Co-primary endpoints were patient-level verified detection rate and region-level positive predictive value against a composite standard of truth (histopathology where available, otherwise confirmatory imaging).\n\nOf 420 men consented, 391 received the tracer and 389 had an evaluable scan. The overall detection rate was 83%, rising from 64% at PSA below 0.5 ng/mL to 100% at higher PSA levels. The verified detection rate (51-54%) met its pre-specified threshold, but the region-level positive predictive value narrowly missed its bar when judged against the composite standard of truth; both endpoints were comfortably met in the subset with histopathology confirmation only (detection rate 81%, PPV 72%). No serious adverse events were attributed to the tracer.\n\nSPOTLIGHT and the companion LIGHTHOUSE trial in newly diagnosed disease together supported FDA approval of flotufolastat F-18 (Posluma). Post-hoc analyses have since reported performance in patients with low PSA, negative baseline conventional imaging, and in African American men.","status":"completed","asOf":"2026-09-22","links":[{"label":"Journal of Urology 2023: SPOTLIGHT primary results (Jani et al.)","url":"https://pubmed.ncbi.nlm.nih.gov/37126069/"},{"label":"ClinicalTrials.gov: NCT04186845","url":"https://clinicaltrials.gov/study/NCT04186845"}],"tags":["diagnostic trial","prostate cancer","biochemical recurrence"],"related":["flotufolastat","psma-pet","prostate-bcr","blue-earth-diagnostics","lighthouse","f-18"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04186845","phase":"3","setting":"Men with biochemical recurrence of prostate cancer after prior curative-intent treatment, being considered for salvage therapy; a diagnostic (imaging) trial","sponsor":"Blue Earth Diagnostics","result":"Overall detection rate 83% by majority read; verified detection rate against a composite standard of truth was 51-54% across readers, meeting the pre-specified threshold, though combined region-level positive predictive value (46-60%) did not (Jani et al., J Urol 2023)","yearReported":2023,"enrolled":391,"enrolledBasis":"registry","outcomes":[{"endpoint":"Verified detection rate vs composite standard of truth (histopathology or confirmatory imaging)","primary":true,"unit":"%","arms":[{"name":"18F-flotufolastat (rhPSMA-7.3) PET-CT","n":366,"value":52,"note":"range 51-54% across 3 readers, exceeding the pre-specified threshold"}],"source":"https://pubmed.ncbi.nlm.nih.gov/37126069/"},{"endpoint":"Region-level positive predictive value","primary":true,"unit":"%","arms":[{"name":"18F-flotufolastat PET-CT","n":366,"value":53,"note":"range 46-60% across readers; did not meet the pre-specified threshold"}],"source":"https://pubmed.ncbi.nlm.nih.gov/37126069/"},{"endpoint":"Overall detection rate, all evaluable scans","unit":"%","arms":[{"name":"18F-flotufolastat PET-CT","n":389,"value":83,"note":"rising from 64% at PSA below 0.5 ng/mL to 100% at higher PSA"}]}]},"route":"/trials/spotlight/","neighbours":{"drug":[{"id":"flotufolastat","kind":"drug","name":"Flotufolastat F-18","route":"/drugs/flotufolastat/"}],"technology":[{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"}],"indication":[{"id":"prostate-bcr","kind":"indication","name":"Biochemical recurrence of prostate cancer","route":"/indications/prostate-bcr/"}],"company":[{"id":"blue-earth-diagnostics","kind":"company","name":"Blue Earth Diagnostics (Bracco)","route":"/companies/blue-earth-diagnostics/"}],"trial":[{"id":"lighthouse","kind":"trial","name":"LIGHTHOUSE","route":"/trials/lighthouse/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"}]}}