CONDOR
A PET scan using a PSMA tracer (piflufolastat F-18, brand Pylarify) was tested in men whose prostate cancer PSA had risen again but standard scans could not find where, to see how reliably it could locate the recurrence.
Overview
CONDOR was a phase 3, prospective, multicentre, open-label, single-arm trial of 18F-DCFPyL (piflufolastat F-18, brand Pylarify) in men with biochemically recurrent prostate cancer and negative or equivocal conventional imaging (CT, MRI, bone scan, or fluciclovine/choline PET). It followed the earlier phase 2/3 OSPREY trial. The primary endpoint was correct localisation rate (CLR): positive predictive value plus a requirement that the PET-positive lesion anatomically co-localised with a composite standard of truth (histopathology, correlative imaging, or post-radiotherapy PSA response).
Of 208 men enrolled (median PSA 0.8 ng/mL), the CLR was 84.8-87.0% across three independent readers, comfortably exceeding the pre-specified threshold, and performance was maintained across all three standard-of-truth categories. 18F-DCFPyL detected at least one lesion in 59-66% of patients, and the scan changed the intended management plan in 63.9% of evaluable patients, most often a shift to targeted radiotherapy.
CONDOR, together with OSPREY, formed the basis of the May 2021 FDA approval of piflufolastat F-18 (Pylarify) for PSMA PET imaging in both initial high-risk staging and biochemical recurrence, one of the tracers that established PSMA PET as standard practice ahead of the confirmatory proPSMA trial.
- 86 out of 100 people reached this endpoint with 18F-DCFPyL (piflufolastat F-18) PET-CT.
- 63.9 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: Men with biochemically recurrent prostate cancer after radical prostatectomy or radiotherapy, with negative or equivocal conventional imaging; a diagnostic (imaging) trial. 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.
208 enrolled.
range 84.8-87.0% across 3 readers (lower bound of 95% CI 77.8-80.4%), meeting the pre-specified >20% threshold
Sourceproportion of evaluable patients with a management change after the scan
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Correct localisation rate vs composite standard of truthprimary | 18F-DCFPyL (piflufolastat F-18) PET-CT | 208 | 86% | - | - | link |
| Change in intended patient management | 18F-DCFPyL PET-CT | - | 63.9% | - | - | - |
Similar pages
not linked directly; found by shared links- TrialSPOTLIGHT
Shares Biochemical recurrence of prostate cancer, PSMA PET, Fluorine-18 and the tags diagnostic trial, prostate cancer, biochemical recurrence.
- TrialFALCON
Shares Biochemical recurrence of prostate cancer, Fluorine-18 and the tags diagnostic trial, prostate cancer, biochemical recurrence.
- TrialLIGHTHOUSE
Shares PSMA PET, Fluorine-18 and the tags diagnostic trial, prostate cancer.
- Key paperAppropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging
Shares Piflufolastat F-18 / Pylarify TruVu, Biochemical recurrence of prostate cancer, PSMA PET, Fluorine-18.
- TermPSMA-RADS (PSMA reporting and data system)
Shares Piflufolastat F-18 / Pylarify TruVu, PSMA PET, Fluorine-18.
- TermPSA kinetics: PSA doubling time and PSA density
- TrialPRINCE
Shares PSMA PET and the tag prostate cancer.
- Key paperLuPSMA trial: single-arm phase 2 study of 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer
Shares PSMA PET and the tag prostate cancer.