SPOTLIGHT
A PET scan (the tracer later approved as Posluma) was tested in men whose PSA rose again after treatment for prostate cancer, to see how often it can find exactly where the cancer has come back.
Overview
SPOTLIGHT was a phase 3, prospective, multicentre, open-label, single-arm imaging trial of 18F-rhPSMA-7.3 (flotufolastat F-18, brand Posluma) in men with biochemically recurrent prostate cancer being considered for salvage therapy. Co-primary endpoints were patient-level verified detection rate and region-level positive predictive value against a composite standard of truth (histopathology where available, otherwise confirmatory imaging).
Of 420 men consented, 391 received the tracer and 389 had an evaluable scan. The overall detection rate was 83%, rising from 64% at PSA below 0.5 ng/mL to 100% at higher PSA levels. The verified detection rate (51-54%) met its pre-specified threshold, but the region-level positive predictive value narrowly missed its bar when judged against the composite standard of truth; both endpoints were comfortably met in the subset with histopathology confirmation only (detection rate 81%, PPV 72%). No serious adverse events were attributed to the tracer.
SPOTLIGHT and the companion LIGHTHOUSE trial in newly diagnosed disease together supported FDA approval of flotufolastat F-18 (Posluma). Post-hoc analyses have since reported performance in patients with low PSA, negative baseline conventional imaging, and in African American men.
- 52 out of 100 people reached this endpoint with 18F-flotufolastat (rhPSMA-7.3) PET-CT.
- 53 out of 100 people reached this endpoint with 18F-flotufolastat PET-CT.
- 83 out of 100 people reached this endpoint with 18F-flotufolastat 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 biochemical recurrence of prostate cancer after prior curative-intent treatment, being considered for salvage therapy; 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.
391 enrolled.
range 51-54% across 3 readers, exceeding the pre-specified threshold
Sourcerange 46-60% across readers; did not meet the pre-specified threshold
Sourcerising from 64% at PSA below 0.5 ng/mL to 100% at higher PSA
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Verified detection rate vs composite standard of truth (histopathology or confirmatory imaging)primary | 18F-flotufolastat (rhPSMA-7.3) PET-CT | 366 | 52% | - | - | link |
| Region-level positive predictive valueprimary | 18F-flotufolastat PET-CT | 366 | 53% | - | - | link |
| Overall detection rate, all evaluable scans | 18F-flotufolastat PET-CT | 389 | 83% | - | - | - |
Similar pages
not linked directly; found by shared links- TrialCONDOR
Shares Biochemical recurrence of prostate cancer, PSMA PET, Fluorine-18 and the tags diagnostic trial, prostate cancer, biochemical recurrence.
- TrialFALCON
Shares Blue Earth Diagnostics (Bracco), Biochemical recurrence of prostate cancer, Fluorine-18 and the tags diagnostic trial, prostate cancer, biochemical recurrence.
- TrialOSPREY
Shares PSMA PET, Fluorine-18 and the tags diagnostic trial, prostate cancer.
- Trial[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
- CompanyBracco Imaging
Shares Blue Earth Diagnostics (Bracco), PSMA PET, Fluorine-18.
- TrialPRINCE
Shares PSMA PET and the tag prostate cancer.
- Key paperAppropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging
Shares Biochemical recurrence of prostate cancer, PSMA PET, Fluorine-18.
- TermPSA kinetics: PSA doubling time and PSA density