(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Wolfgang Fendler discussing PSMA-PET and PROMISE re-defining stage and risk in patients with prostate cancer.
PSMA-PET was introduced in 2012 and has since significantly transformed the staging of prostate cancer. Since then, in 2016, the PROMISE criteria were proposed to standardize PSMA-PET reporting. At the ESMO 2024 annual meeting, Dr. Fendler and colleagues compared the prognostic value of PSMA-PET by PROMISE stage head-to-head with established clinical risk scores in a large prostate cancer dataset with overall survival follow-up.
All prostate cancer patients, who underwent PSMA-PET at the Essen University Hospital between 2014 and 2021, were randomly split into development and validation cohorts (2:1). Patients from University Hospitals in Münster, Freiburg, and Dresden, Germany, were included as external validation cohort. Dr. Fendler and colleagues created a quantitative and visual PSMA-PET by PROMISE nomogram based on Cox regression models with LASSO penalty for overall survivalinn the Development cohort. Accuracy was measured using C-index and head-to-head comparison to clinical risk scores (STARCAP Nomogram, EAU Risk Group, NCCN risk group, GAFITA Nomogram) using ROC curves. The PSMA-PET metrics by PROMISE are as follows:1-2
The investigators analyzed 2,414 patients (1,110 development, 502 internal and 802 external validation) with 901 (37.3%) deaths across all disease stages (median follow-up 52.9 months (IQR 33.9-79.0). Predictors in the quantitative PSMA-PET by PROMISE nomogram were locoregional lymph node metastases (miN2), distant metastases (miM1a, miM1b pattern, miM1c), tumor volume, and tumor SUVmean. The visual PSMA-PET by PROMISE nomogram includes distant metastases and total tumor lesion count. C-indices in the internal and external validation cohorts were 0.80 and 0.77 (quantitative) or 0.78 and 0.77 (visual), respectively. The following shows overall survival curves for all patients, as well as for biochemical recurrence, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer subgroups:
The quantitative PSMA-PET by PROMISE nomogram was superior to STARCAP at initial staging (n = 139; AUC: 0.73 vs. 0.54; p = 0.02), to EAU risk score at biochemical recurrence (n = 412; AUC: 0.69 vs. 0.52; p < 0.001), and to NCCN subgroups at any time point (n = 1534; AUC: 0.81 vs. 0.74; p < 0.001). The visual PSMA-PET by PROMISE nomogram was superior to EAU at biochemical recurrence (n = 414; AUC: 0.64 vs. 0.52; p < 0.001) and NCCN subgroups at any time point (n = 1,544; AUC: 0.79 vs. 0.73; p < 0.001).
Dr. Fendler concluded his presentation discussing PSMA-PET and PROMISE re-defining stage and risk in patients with prostate cancer with the following take-home points:
- PSMA-PET PROMISE is a novel independent quantitative prognostic biomarker for early and late stages of prostate cancer
- Both PSMA-PET PROMISE nomograms revealed equal or superior prediction of overall survival compared to established clinical risk scores
- These nomograms support longitudinal risk assessment in clinical trials and routine practice
- Validation with long-term follow-up is ongoing (NCT06320223, promise-pet.com)
Presented by: Wolfgang P. Fendler, MD, West German Cancer Center, University Hospital Essen, Essen, Germany
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2024 European Society of Medical Oncology (ESMO) Annual Meeting, Barcelona, Spain, Fri, Sept 13 – Tues, Sept 17, 2024.
References:
- Seifert R, Emmett L, Rowe SP, et al. Second Version of the Prostate Cancer Molecular Imaging Standardized Evaluation Framework Including Response Evaluation for Clinical Trials (PROMISE V2). Eur Urol. 2023 May;83(5):405-412.
- Eiber M, Herrmann K, Calais J, et al. Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE): Proposed miTNM Classification for the Interpretation of PSMA-Ligand PET/CT. J Nucl Med. 2018 Mar;59(3):469-478.