{"entity":{"id":"osprey","kind":"trial","name":"OSPREY","aka":["18F-DCFPyL staging and recurrence trial"],"tldr":"An earlier study of the same PSMA PET scan later branded Pylarify, testing how well it detects lymph node spread before surgery in high-risk prostate cancer, and how well it confirms recurrent or spreading disease when a biopsy is possible.","summary":"OSPREY was a prospective, multicentre phase 2/3 trial of 18F-DCFPyL (piflufolastat F-18, brand Pylarify) with two cohorts. Cohort A (252 evaluable patients) evaluated sensitivity and specificity for pelvic lymph node metastases in men with high-risk prostate cancer planned for prostatectomy with lymphadenectomy, using surgical histopathology as the reference. Cohort B (93 evaluable patients) evaluated sensitivity and positive predictive value for detecting prostate cancer at sites of suspected recurrence or metastasis, verified by biopsy.\n\nIn Cohort A, specificity (97.9%) met its pre-specified threshold but sensitivity (40.3%) did not, a pattern later echoed in LIGHTHOUSE and consistent with the difficulty PSMA PET has detecting small-volume nodal disease. In Cohort B, sensitivity (95.8%) and positive predictive value (81.9%) for extraprostatic lesions were high. The tracer was well tolerated, with drug-related adverse events in 7.0% of patients.\n\nOSPREY was the earlier of the two pivotal trials (with CONDOR) supporting the May 2021 FDA approval of piflufolastat F-18 (Pylarify).","status":"completed","asOf":"2026-09-22","links":[{"label":"J Urol 2021: OSPREY primary results (Pienta et al.)","url":"https://pubmed.ncbi.nlm.nih.gov/33634707/"},{"label":"ClinicalTrials.gov: NCT02981368","url":"https://clinicaltrials.gov/study/NCT02981368"}],"tags":["diagnostic trial","prostate cancer","staging"],"related":["pylarify","psma-pet","prostate-high-risk","condor","f-18"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02981368","phase":"2/3","setting":"Cohort A: men with high-risk prostate cancer planned for radical prostatectomy with lymphadenectomy (initial staging). Cohort B: men with suspected recurrent or metastatic prostate cancer feasible for biopsy","sponsor":"Progenics Pharmaceuticals","result":"Cohort A: specificity 97.9% met the primary endpoint but sensitivity 40.3% did not; Cohort B: sensitivity 95.8% and PPV 81.9% for extraprostatic lesions (Pienta et al., J Urol 2021)","yearReported":2021,"enrolled":385,"enrolledBasis":"registry","outcomes":[{"endpoint":"Specificity for pelvic nodal disease, Cohort A, vs histopathology at prostatectomy","primary":true,"unit":"%","arms":[{"name":"18F-DCFPyL PET-CT","n":252,"value":97.9,"note":"median 95% CI 94.5-99.4% across 3 readers, meeting the pre-specified threshold"}],"source":"https://pubmed.ncbi.nlm.nih.gov/33634707/"},{"endpoint":"Sensitivity for pelvic nodal disease, Cohort A, vs histopathology","primary":true,"unit":"%","arms":[{"name":"18F-DCFPyL PET-CT","n":252,"value":40.3,"note":"median 95% CI 28.1-52.5%; did not meet the pre-specified threshold"}],"source":"https://pubmed.ncbi.nlm.nih.gov/33634707/"},{"endpoint":"Sensitivity for extraprostatic lesions, Cohort B, vs biopsy","unit":"%","arms":[{"name":"18F-DCFPyL PET-CT","n":93,"value":95.8,"note":"median 95% CI 87.8-99.0%; PPV 81.9%"}]}]},"route":"/trials/osprey/","neighbours":{"drug":[{"id":"pylarify","kind":"drug","name":"Piflufolastat F-18 / Pylarify TruVu","route":"/drugs/pylarify/"}],"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/"}],"trial":[{"id":"condor","kind":"trial","name":"CONDOR","route":"/trials/condor/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"}]}}