{"entity":{"id":"lighthouse","kind":"trial","name":"LIGHTHOUSE","aka":["18F-rhPSMA-7.3 newly diagnosed prostate cancer trial"],"tldr":"A PET scan using a PSMA-targeting tracer (later approved as Posluma) was tested in men newly diagnosed with high-risk prostate cancer to see how well it spots cancer that has already spread to lymph nodes or elsewhere in the body before surgery.","summary":"LIGHTHOUSE was a phase 3, prospective, multicentre, single-arm imaging trial of 18F-rhPSMA-7.3 (later named flotufolastat F-18, brand Posluma) in men with newly diagnosed unfavourable intermediate- to very-high-risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection. The co-primary endpoints were patient-level sensitivity and specificity for pelvic lymph node metastases, using histopathology at lymphadenectomy as the reference standard, evaluated by three blinded independent readers.\n\nOf 356 enrolled patients, 296 formed the efficacy analysis population. Specificity was high (93-97%) and met the pre-specified threshold for all readers, but sensitivity (23-30%) fell short of the statistical bar, consistent with the modest nodal sensitivity typical of PSMA PET tracers as a class. A separate analysis of extrapelvic (M1) findings, reported at ASCO GU 2023, found a verified detection rate of 10-15% among 335 men, concentrated in bone. No serious adverse events were observed.\n\nLIGHTHOUSE, alongside the companion SPOTLIGHT trial in biochemical recurrence, formed the basis of the FDA approval of flotufolastat F-18 (Posluma) for PSMA PET imaging in both newly diagnosed unfavourable-risk and recurrent prostate cancer.","status":"completed","asOf":"2026-09-22","links":[{"label":"European Urology 2023: LIGHTHOUSE primary results","url":"https://pubmed.ncbi.nlm.nih.gov/37414702/"},{"label":"ClinicalTrials.gov: NCT04186819","url":"https://clinicaltrials.gov/study/NCT04186819"},{"label":"Blue Earth Diagnostics: LIGHTHOUSE topline results announcement","url":"https://www.itnonline.com/content/blue-earth-diagnostics-announces-efficacy-and-safety-results-phase-3-lighthouse-trial"}],"tags":["diagnostic trial","prostate cancer","staging"],"related":["flotufolastat","psma-pet","prostate-high-risk","blue-earth-diagnostics","spotlight","f-18"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04186819","phase":"3","setting":"Men with newly diagnosed, treatment-naive unfavourable intermediate- to very-high-risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection; a staging (diagnostic) trial","sponsor":"Blue Earth Diagnostics","result":"Specificity for pelvic lymph node metastases met the pre-specified threshold (93-97% across readers) but sensitivity did not (23-30%); the agent additionally identified distant (M1) lesions, later verified true-positive in 10-15% of men (Eur Urol 2023; ASCO GU 2023)","yearReported":2023,"enrolled":356,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for pelvic lymph node metastases vs histopathology at prostatectomy","primary":true,"unit":"%","arms":[{"name":"18F-flotufolastat (rhPSMA-7.3) PET-CT","n":296,"value":27,"note":"range 23-30% across 3 readers; did not meet the 22.5% lower-CI threshold for 2 of 3 readers"}],"source":"https://pubmed.ncbi.nlm.nih.gov/37414702/"},{"endpoint":"Specificity for pelvic lymph node metastases vs histopathology at prostatectomy","primary":true,"unit":"%","arms":[{"name":"18F-flotufolastat (rhPSMA-7.3) PET-CT","n":296,"value":95,"note":"range 93-97% across 3 readers, exceeding the 82.5% pre-specified threshold"}],"source":"https://pubmed.ncbi.nlm.nih.gov/37414702/"},{"endpoint":"Verified detection rate of distant (M1) lesions","unit":"%","arms":[{"name":"18F-flotufolastat PET-CT, verified by biopsy or confirmatory imaging","n":335,"value":12,"note":"range 10-15%; highest in bone (6.0-11%)"}]}]},"route":"/trials/lighthouse/","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-high-risk","kind":"indication","name":"Localised prostate cancer, high and very high risk","route":"/indications/prostate-high-risk/"}],"company":[{"id":"blue-earth-diagnostics","kind":"company","name":"Blue Earth Diagnostics (Bracco)","route":"/companies/blue-earth-diagnostics/"}],"trial":[{"id":"spotlight","kind":"trial","name":"SPOTLIGHT","route":"/trials/spotlight/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"}]}}