# OSPREY

Source: https://nuclide.cc/trials/osprey/  
Nuclide record `osprey` (Trial). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

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.

In 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.

OSPREY was the earlier of the two pivotal trials (with CONDOR) supporting the May 2021 FDA approval of piflufolastat F-18 (Pylarify).

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-22
- Also known as: 18F-DCFPyL staging and recurrence trial
- Tags: diagnostic trial; prostate cancer; staging
- Registry id: 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
- Enrolled: 385
- 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)
- Outcomes: Specificity for pelvic nodal disease, Cohort A, vs histopathology at prostatectomy: 18F-DCFPyL PET-CT 97.9%; Sensitivity for pelvic nodal disease, Cohort A, vs histopathology: 18F-DCFPyL PET-CT 40.3%; Sensitivity for extraprostatic lesions, Cohort B, vs biopsy: 18F-DCFPyL PET-CT 95.8%

## Sources

- J Urol 2021: OSPREY primary results (Pienta et al.): https://pubmed.ncbi.nlm.nih.gov/33634707/
- ClinicalTrials.gov: NCT02981368: https://clinicaltrials.gov/study/NCT02981368

## Connected records

- drugs: [Piflufolastat F-18 / Pylarify TruVu](https://nuclide.cc/drugs/pylarify/)
- technologies: [PSMA PET](https://nuclide.cc/technologies/psma-pet/)
- indications: [Localised prostate cancer, high and very high risk](https://nuclide.cc/indications/prostate-high-risk/)
- trials: [CONDOR](https://nuclide.cc/trials/condor/)
- isotopes: [Fluorine-18](https://nuclide.cc/isotopes/f-18/)

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