proPSMA
Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study
N = 302
- Population
- Men with biopsy-proven prostate cancer and high-risk features before curative-intent surgery or radiotherapy (339 assessed for eligibility).
- Design
- Multicentre, two-arm, randomised study at ten hospitals in Australia (March 2017 to November 2018). Men were randomly assigned to first-line imaging with CT and bone scanning or with gallium-68 PSMA-11 PET-CT, done within 21 days of randomisation; patients crossed over to the other imaging unless three or more distant metastases were identified. Primary outcome: accuracy of first-line imaging for pelvic nodal or distant-metastatic disease, against a predefined reference standard (histopathology, imaging and biochemistry at 6-month follow-up).
- Primary endpoint
- Diagnostic accuracy
- Arms
- CT and bone scan (control, n = 152): Conventional imaging with CT and bone scanning
- PSMA PET-CT (experimental, n = 150): Gallium-68 PSMA-11 PET-CT
- People
- Hofman MS, proPSMA Study Group Collaborators
Δ Diagnostic accuracy+27 pointsΔ Diagnostic sensitivity+47 pointsΔ Diagnostic specificity+7 points
Show the numbers
| Endpoint | Analysis | PSMA PET-CT | CT and bone scan | Effect |
|---|---|---|---|---|
| Diagnostic accuracyRandomised men; 295 (98%) had follow-up, of whom 87 (30%) had pelvic nodal or distant metastatic disease (the abstract does not state the analysis set for each figure)Accuracy of first-line imaging for identifying pelvic nodal or distant-metastatic disease, defined by the receiver-operating curve against the predefined reference standard. | primaryHofman 2020 | 92% (88–95%) | 65% (60–69%) | P<0.0001PSMA PET-CT accuracy was 27% (95% CI 23-31) greater than that of conventional imaging. Area under the curve for pelvic nodal metastases 91% (PSMA PET-CT) vs 59%; for distant metastases 95% vs 74%. |
| Diagnostic sensitivityRandomised men with follow-up (295 of 302)Sensitivity of first-line imaging for pelvic nodal or distant-metastatic disease against the predefined reference standard. | primaryHofman 2020 | 85% (74–96%) | 38% (24–52%) | — |
| Diagnostic specificityRandomised men with follow-up (295 of 302)Specificity of first-line imaging for pelvic nodal or distant-metastatic disease against the predefined reference standard. | primaryHofman 2020 | 98% (95–100%) | 91% (85–97%) | — |
| Endpoint | Analysis | PSMA PET-CT | CT and bone scan | Effect |
|---|---|---|---|---|
| Diagnostic accuracyRandomised men; 295 (98%) had follow-up, of whom 87 (30%) had pelvic nodal or distant metastatic disease (the abstract does not state the analysis set for each figure)Accuracy of first-line imaging for identifying pelvic nodal or distant-metastatic disease, defined by the receiver-operating curve against the predefined reference standard. | primaryHofman 2020 | 92% (88–95%) | 65% (60–69%) | P<0.0001PSMA PET-CT accuracy was 27% (95% CI 23-31) greater than that of conventional imaging. Area under the curve for pelvic nodal metastases 91% (PSMA PET-CT) vs 59%; for distant metastases 95% vs 74%. |
| Diagnostic sensitivityRandomised men with follow-up (295 of 302)Sensitivity of first-line imaging for pelvic nodal or distant-metastatic disease against the predefined reference standard. | primaryHofman 2020 | 85% (74–96%) | 38% (24–52%) | — |
| Diagnostic specificityRandomised men with follow-up (295 of 302)Specificity of first-line imaging for pelvic nodal or distant-metastatic disease against the predefined reference standard. | primaryHofman 2020 | 98% (95–100%) | 91% (85–97%) | — |
Appears in
Sources
Hofman MS, Lawrentschuk N, Francis RJ, Tang C, Vela I, Thomas P, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395(10231):1208-1216.