Abstract

This study used linked, routinely-collected datasets to explore incidence, clinical characteristics and outcomes of prostate cancer (PC) patients who experience a rise in prostate-specific antigen (PSA) levels despite androgen deprivation therapy (ADT), without evidence of metastases in their patient record, termed non-metastatic castration-resistant PC (nmCRPC). Routinely collected administrative data in Wales were used to identify patients diagnosed with PC and nmCRPC from 2000–2015. Logrank tests and Cox proportional hazard models were used to compare time-to-events across subgroups defined by PSA doubling time and age. Of 38,021 patients identified with PC, 1,465 met nmCRPC criteria. PC incidence increased over the study period, while nmCRPC categorizations reduced. Median time from PC diagnosis to nmCRPC categorization was 3.07 years (95% confidence interval [CI] 2.91–3.26) and from nmCRPC categorization to metastases/death was 2.86 years (95% CI 2.67–3.09). Shorter PSA doubling time (≤ 10 months, versus > 10 months) was associated with reduced time to metastases or death (2.11 years [95% CI 1.92–2.30] versus 5.22 years [95% CI 4.87–5.51]). Age was not significantly associated with time to metastases/death. Our findings highlight key clinical characteristics and outcomes for patients with nmCRPC prior to the introduction of recently approved treatments.

Highlights

  • This study used linked, routinely-collected datasets to explore incidence, clinical characteristics and outcomes of prostate cancer (PC) patients who experience a rise in prostate-specific antigen (PSA) levels despite androgen deprivation therapy (ADT), without evidence of metastases in their patient record, termed non-metastatic castration-resistant PC

  • Palliative treatment options for patients with PC are based around androgen deprivation therapy (ADT), which initially elicits a response in most patients with castration-sensitive prostate cancer (CSPC)[3]

  • Between 01 January 2000 and 31 December 2015, 38,021 men were diagnosed with PC, of which 1,465 (3.9%) were further categorized with non-metastatic castration-resistant PC (nmCRPC) based on our main cohort definition, and 470 (1.2%) patients were categorized with nmCRPC using the stringent subset definition (Supplementary Figure S1)

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Summary

Introduction

This study used linked, routinely-collected datasets to explore incidence, clinical characteristics and outcomes of prostate cancer (PC) patients who experience a rise in prostate-specific antigen (PSA) levels despite androgen deprivation therapy (ADT), without evidence of metastases in their patient record, termed non-metastatic castration-resistant PC (nmCRPC). Recent data support the use of enzalutamide, apalutamide, and darolutamide in patients with nmCRPC and a PSA doubling time of ≤ 10 months, on the basis of a metastasis-free survival b­ enefit[8,9,10] These relatively recent therapeutic options for nmCRPC highlight the importance of documenting accurate real-world incidence, clinical characteristics and outcomes to inform treatment needs. We aimed to describe key clinical characteristics and outcomes of this patient population and identify potential risk factors for early disease progression or mortality

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