Discussion
±, prostate cancer, ’
BONE LESIONS, DISEASE, PROSTATE CANCER
In this prospective, cross-over, open-label study, per-patient DR, impact on PM and safety profiles were evaluated and compared for [PYTHON is the first comparative study, with randomized treatment administration of ‘next generation imaging’ without censorship by conventional imaging. Another phase III prospective, single-arm study, CONDOR, has evaluated the diagnostic performance and safety of [The diagnostic performance of [Per-patient DR in the PYTHON study was significantly higher for [In PYTHON, per-patient DR according to PSA concentration level at first injection for patients after RP ± eLND (observed case) tended to be higher for [Another explanation may be the intra-reader variability (i.e., comparison of readings made twice by a same reader), which was evaluated by the Cohen’s Kappa coefficient. The overall Cohen’s Kappa was 0.54 [95% CI 0.39; 0.68]. This low value, considered as moderate according to Landis and Koch classification, was due to reader 3. Indeed, this reader reported only a Cohen’s Kappa [95% CI] of 0.33 [0.05; 0.62]. On the contrary, reader 1 and 2 obtained a Cohen’s kappa of 0.64 [0.40; 0.88] and 0.62 [0.39; 0.84], considered as substantial. The interobserver variability of three clinically frequently used PSMA tracers in PCa was previously discussed by Hagens et al., concluding that training on interpretation is essential [In a meta-analysis including 5 studies and 257 BCR PCa patients, Treglia et al. performed a head-to-head comparison between choline and PSMA in BCR PCa [In the PYTHON study, PM was changed by the PET/CTs in 49% of the cases, with an impact of [Regarding the acquisition parameters, [An important aspect when visually interpreting the PSMA PET/CT scans is the non-specific bone activity. Although in present study the number of bone lesions visualised on the [In this study, the intra-reader variability was low. Intra-reader variability is usually linked to deviation from study-specific image interpretation criteria on which readers have been trained, while inter-reader variability links essentially to readers’ skill. Since PET/CT readers were trained nuclear medicine physicians with track record in prostate cancer imaging, including PSMA interpretation, other possible reasons were revised for final recommendations. Our conclusion is that in order to reduce the variability, it is recommended to standardized image acquisition, to uniform the available information using the blinded setting, to standardize reader training, and to retrain the readers in case of substantial discordance is identified.As part of the routine care practice, enrolled patients received appropriate treatment and follow-up, in a multicentre frame. The investigating sites were requested for the period of up to 10 months after the second tracer injection, to provide any results of subsequent biopsies, imaging studies, clinical findings, PSA measurements, and disease management if performed in routine practice. However, this study was not devoid of limitations. Contrary to other studies in BCR population, no standard of truth was used. Thus, treatment decisions were pragmatic, made at the discretion of the referring physician, and based on all available clinical information. Local reports of both PET/CT scans were not standardised, but followed the clinical routine, with positive findings not always being confirmed by histopathology.