A US real-world study of treatment patterns and outcomes in localized or locally advanced prostate cancer patients.

Men with localized or locally advanced prostate cancer (LPC/LAPC) are at risk of progression after radiotherapy (RT) or radical prostatectomy (RP). Using real-world data, we evaluated patient characteristics, treatment patterns, and outcomes in LPC/LAPC.

Optum claims and electronic health records (EHR) data from January 2010 to December 2021 were queried for men with LPC/LAPC who received primary RT, RP, or androgen deprivation therapy alone within 180 days after diagnosis. Survival outcomes were analyzed using descriptive statistics and Kaplan-Meier curves. Real-world overall survival (rwOS) was compared in patients with and without evidence of disease (i.e., disease recurrence, metastasis, diagnosis of castration-resistant PC) at defined time points.

61,772 and 62,361 men in claims and EHR cohorts met the inclusion criteria. Median follow-up was 719 and 901 days, respectively. Most men received primary RT (51.0% claims, 35.0% EHR) or RP (39.4% claims, 53.8% EHR). Survival was greatest among men treated with RP, followed by RT. Adjusted for age and comorbidity, rwOS was shorter among men with evidence of disease within 1, 3, 4, and 5 years after primary treatment than those without at the same time points.

Real-world claims and EHR data show that survival among men with LPC/LAPC differs by primary treatment and time point of disease recurrence thereafter. Poor outcomes in men with LPC/LAPC who progress early indicate an unmet medical need for more effective primary treatment. If validated for surrogacy, no evidence of disease at specific time points could represent an intermediate efficacy endpoint in future trials.

World journal of urology. 2023 Nov 15 [Epub ahead of print]

Stephen J Freedland, Sandhya Nair, Xiwu Lin, Lawrence Karsh, Christopher Pieczonka, Ravi Potluri, Sabine D Brookman-May, Suneel D Mundle, Sarah Fleming, Neeraj Agarwal

Cedars-Sinai Medical Center, Los Angeles, CA, USA. ., Janssen Pharmaceutica NV, Beerse, Belgium., Janssen Global Services, Horsham, PA, USA., The Urology Center of Colorado, Denver, CO, USA., Associated Medical Professionals of NY, Syracuse, NY, USA., Putnam Associates, HEOR & RWE, New York, NY, USA., Janssen Research & Development, Spring House, PA, USA., Janssen Global Services, Raritan, NJ, USA., Janssen Global Services, Titusville, NJ, USA., Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.