OnCo
trialsTrialPositive

proPSMA

Proved PSMA PET is far more accurate than conventional scans for staging, with less radiation.

302 men; accuracy 92% vs 65%; fewer equivocal findings; changed management in 28% vs 15%. Lancet 2020.

Setting
High-risk localised prostate cancer staging: PSMA PET/CT vs CT + bone scan
Phase
Phase 3
Sponsor
Peter MacCallum Cancer Centre / ANZUP
Headline result
Accuracy 92% vs 65%.
Reported
2020
Enrolled
302
Replication
Consistent with the OSPREY and CONDOR registrational studies for 18F-DCFPyL.

Outcomes

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In plain words
What these results mean for people, not percentages
302 people took part
Accuracy for pelvic nodal or distant metastases (AUC)primaryother endpoint
  • 92 vs 65 out of 100 reached this endpoint with PSMA PET/CT compared with CT + bone scan; 27 more per 100.
  • Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
  • 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: High-risk localised prostate cancer staging: PSMA PET/CT vs CT + bone scan. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (PSMA); the result should not be assumed for people whose cancer does not have it.

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.

302 participants enrolled.

Accuracy for pelvic nodal or distant metastases (AUC)primary
· p <0.0001
PSMA PET/CT92 of 100
n = 150
CT + bone scan65 of 100
n = 152
Source
EndpointArmnValueHR (95% CI)pSource
Accuracy for pelvic nodal or distant metastases (AUC)primaryPSMA PET/CT15092%<0.0001link
CT + bone scan15265%
Replication
Consistent with the OSPREY and CONDOR registrational studies for 18F-DCFPyL.

Connected

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