Treatment of intermediate-risk prostate cancer with active surveillance in the routine care—Long-term outcomes of a prospective noninterventional study (HAROW)

Abstract

Background: We report here the long-term outcomes of patients with intermediate-risk prostate cancer (PCa) treated with active surveillance (AS) in a daily routine setting.

Material and methods: HAROW (2008-2013) was a noninterventional, health service research study investigating the management of localized PCa in a community setting. A substantial proportion of the study centers were office-based urologists. A follow-up examination of all intermediate-risk patients with AS was conducted. Overall, cancer-specific, metastasis-free, and treatment-free survival rates, as well as reasons for discontinuation, were determined and discussed.

Results: Of the 2957 patients enrolled, 52 with intermediate-risk PCa were managed with AS and were available for evaluation. The median follow-up was 6.8 years (interquartile range, 3.4-8.6 years). Seven patients (13.5%) died of causes unrelated to PCa, of whom 4 were under AS or under watchful waiting. Two patients (3.8%) developed metastasis. The estimated 8-year overall, cancer-specific, metastasis-free, and treatment-free survival rates were 85% (95% confidence interval [CI], 72%-96%), 100%, 93% (95% CI, 82%-100%), and 31% (95% CI, 17%-45%), respectively. On multivariable analysis, prostate-specific antigen density of ≥0.2 ng/mL² was significantly predictive of receiving invasive treatment (hazard ratio, 3.29; p = 0.006). Reasons for discontinuation were more often due to patient's or physician's concerns (36%) than due to observed clinical progression.

Conclusions: Although survival outcome data for intermediate-risk patients managed with AS in real-life health care conditions were promising, rates of discontinuation were high, and discontinuation was often a patient's decision, even when the signs of disease progression were absent. This might be an indication of higher levels of mental burden and anxiety in this specific subgroup of patients, which should be considered when making treatment decisions. From a psychological perspective, not all intermediate-risk patients are optimal candidates for AS.

Keywords

Active surveillance / Intermediate-risk prostate cancer / HAROW study / Conservative management / Outcomes research

Acknowledgments

None.

Statement of ethics

This study was approved by the ethics committee of the Bavarian State Board of Physicians (no. 08012). It was registered under study ID “479” at the German Cancer Study Registry (DKSR; February 2008). Informed consent was obtained from all the participants included in the study. All procedures performed in the trial involving human participants were in accordance with the 1964 Declaration of Helsinki and its later amendments.

Conflict of interest statement

JH, AS, and EAB declare that they have no conflict of interest. LW has acted as a paid consultant for the Scientific Institute (WIdO) of the statutory AOK health insurance provider. He has received study support (third-party funding) from Gazprom Germania.

Funding source

The HAROW study was initiated and conducted by the Men's Health Foundation, Berlin, Germany and financially supported by Gazprom Germania with an unconditional grant for data collection and data management.

Author contributions

JH: Project development, data analysis, manuscript writing;

AS: Data collection, management, and analysis;

EAB: Manuscript editing;

LW: Project development, data analysis, manuscript editing.

Data availability

The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.

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