proPSMA
Is PSMA PET/CT more accurate than conventional imaging for initial staging of high-risk prostate cancer?
One underlying study; aliases and follow-up reports consolidated. Primary discipline: Imaging.
302 men with high-risk prostate cancer being considered for curative-intent treatment.
High-risk staging; this is diagnostic accuracy and management impact, not a survival trial.
302 randomised/evaluable as reported.
Gallium-68 PSMA PET/CT.
CT plus bone scintigraphy.
Endpoints and results
Primary diagnostic accuracy for pelvic nodal/distant metastasis; management change, equivocal findings and radiation exposure secondary.
- Diagnostic accuracy 92% vs 65% (absolute difference 27 percentage points; p<0.0001).
- Sensitivity 85% vs 38%; specificity 98% vs 91%.
- Management changed in 28% vs 15%; equivocal findings 7% vs 23%.
Absolute Effect and outcome visualisation
Diagnostic accuracy
% correctly classified · Initial staging. Bars show reported fixed-time percentages.
Interpretation: The 27-point accuracy improvement is not an NNT for preventing recurrence or death. NNT is not appropriate without a patient-outcome endpoint.
Toxicity, discontinuation and quality of life
Trial-specific harms: Radiation exposure, false-positive findings and downstream investigations/treatment changes; fewer equivocal findings with PSMA PET/CT.
Treatment burden/discontinuation: Imaging strategy can alter downstream tests and treatment plans; this is not a systemic-treatment discontinuation outcome.
Quality of life: No direct QoL or survival benefit established by this diagnostic trial.
Subgroups, maturity and limitations
Subgroups: Study population was high-risk prostate cancer; do not extrapolate to all risk groups without evidence.
Maturity: Prospective randomised multicentre diagnostic trial published 2020.
Limitations: Improved accuracy and management change do not prove improved OS or QoL.
proPSMA demonstrated superior staging accuracy over conventional imaging in high-risk prostate cancer, but was not a survival trial.
Current-practice context must be checked against regional guidelines, patient fitness, biomarkers, alternatives and regulatory status before clinical application. Clinical freshness review and browser-rendered QA remain pending.
Primary sources and registry
Registry: NCT02919111
The Absolute Effect · Updated 26 October 2026 · Never derive NNT from median survival.