OnCo
ideasIdea

Qualify PSMA PET tumour volume as a validated imaging biomarker

PSMA scans could measure prostate cancer burden and response far better than PSA, but no one has done the standardisation work to make the measurement trustworthy across scanners.

Total PSMA-positive tumour volume and SUV metrics predict outcome in metastatic prostate cancer and response to radioligand therapy, but acquisition, reconstruction and segmentation vary between centres. A QIBA-style profile (phantom calibration, harmonised reconstruction, validated segmentation software) followed by biomarker qualification for defined contexts of use (prognosis, response assessment) would let PSMA volume be used as an endpoint and selection tool in trials.

Hypothesis
Harmonised PSMA volumetric measurements will achieve test-retest and inter-site coefficient of variation under 15% and will predict overall survival on radioligand therapy better than PSA response.
Rationale
FDG PET response criteria (PERCIST, Deauville) needed the same standardisation before adoption; PSMA PET is now widespread enough to justify it.
What would test it
A multi-centre phantom and test-retest study followed by retrospective validation on trial imaging from VISION and PSMAfore, then a qualification submission.
Maturity
early clinical
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
4
Bottlenecks it attacks

Connected

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Pages like this

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cancers

1
Prostate cancer

technologies

2
PET/CTPSMA PET

pairings

1
PSMA PET → PSMA radioligand therapy

ideas

1
Total-body PET for personalised radioligand dosing

bottlenecks

1
Biomarkers are not validated or standardised