LIGHTHOUSE
A PET scan using a PSMA-targeting tracer (later approved as Posluma) was tested in men newly diagnosed with high-risk prostate cancer to see how well it spots cancer that has already spread to lymph nodes or elsewhere in the body before surgery.
Overview
LIGHTHOUSE was a phase 3, prospective, multicentre, single-arm imaging trial of 18F-rhPSMA-7.3 (later named flotufolastat F-18, brand Posluma) in men with newly diagnosed unfavourable intermediate- to very-high-risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection. The co-primary endpoints were patient-level sensitivity and specificity for pelvic lymph node metastases, using histopathology at lymphadenectomy as the reference standard, evaluated by three blinded independent readers.
Of 356 enrolled patients, 296 formed the efficacy analysis population. Specificity was high (93-97%) and met the pre-specified threshold for all readers, but sensitivity (23-30%) fell short of the statistical bar, consistent with the modest nodal sensitivity typical of PSMA PET tracers as a class. A separate analysis of extrapelvic (M1) findings, reported at ASCO GU 2023, found a verified detection rate of 10-15% among 335 men, concentrated in bone. No serious adverse events were observed.
LIGHTHOUSE, alongside the companion SPOTLIGHT trial in biochemical recurrence, formed the basis of the FDA approval of flotufolastat F-18 (Posluma) for PSMA PET imaging in both newly diagnosed unfavourable-risk and recurrent prostate cancer.
- 27 out of 100 people reached this endpoint with 18F-flotufolastat (rhPSMA-7.3) PET-CT.
- 95 out of 100 people reached this endpoint with 18F-flotufolastat (rhPSMA-7.3) PET-CT.
- 12 out of 100 people reached this endpoint with 18F-flotufolastat PET-CT, verified by biopsy or confirmatory imaging.
- 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 newly diagnosed, treatment-naive unfavourable intermediate- to very-high-risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection; a staging (diagnostic) 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.
356 enrolled.
range 23-30% across 3 readers; did not meet the 22.5% lower-CI threshold for 2 of 3 readers
Sourcerange 93-97% across 3 readers, exceeding the 82.5% pre-specified threshold
Sourcerange 10-15%; highest in bone (6.0-11%)
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Sensitivity for pelvic lymph node metastases vs histopathology at prostatectomyprimary | 18F-flotufolastat (rhPSMA-7.3) PET-CT | 296 | 27% | - | - | link |
| Specificity for pelvic lymph node metastases vs histopathology at prostatectomyprimary | 18F-flotufolastat (rhPSMA-7.3) PET-CT | 296 | 95% | - | - | link |
| Verified detection rate of distant (M1) lesions | 18F-flotufolastat PET-CT, verified by biopsy or confirmatory imaging | 335 | 12% | - | - | - |
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