OSPREY
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.
Overview
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).
- 97.9 out of 100 people reached this endpoint with 18F-DCFPyL PET-CT.
- 40.3 out of 100 people reached this endpoint with 18F-DCFPyL PET-CT.
- 95.8 out of 100 people reached this endpoint with 18F-DCFPyL PET-CT.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
385 enrolled.
median 95% CI 94.5-99.4% across 3 readers, meeting the pre-specified threshold
Sourcemedian 95% CI 28.1-52.5%; did not meet the pre-specified threshold
Sourcemedian 95% CI 87.8-99.0%; PPV 81.9%
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Specificity for pelvic nodal disease, Cohort A, vs histopathology at prostatectomyprimary | 18F-DCFPyL PET-CT | 252 | 97.9% | - | - | link |
| Sensitivity for pelvic nodal disease, Cohort A, vs histopathologyprimary | 18F-DCFPyL PET-CT | 252 | 40.3% | - | - | link |
| Sensitivity for extraprostatic lesions, Cohort B, vs biopsy | 18F-DCFPyL PET-CT | 93 | 95.8% | - | - | - |
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