Login to Access Video or Poster Abstract: MP43-09
Sources of Funding: The HAROW study was initiated and conducted by the Foundation of Men's Health and financially supported by Gazprom Germania.

Introduction

Active Surveillance (AS) is a treatment option for selected patients with localized prostate cancer (PCa) and low risk for progression. Most data on AS result from clinical trials, conducted at academic- or tertiary care centers. In contrast, in clinical practice AS is mostly applied by office based urologists. In this prospective, non-interventional, health services research study the use of five treatment options for localized PCa were compared under everyday conditions: Hormone therapy (HT), AS, Radiation therapy (RT), Operation (RP) and Watchful waiting (WW). Data of the AS-subgroup are presented in terms of inclusion criteria and changes in treatment strategy.

Methods

The study was conducted from July 2008 to July 2013 at 259 study centers in Germany, in 86% office based urologists. Clinical data (tumor category, digital rectal examination, PSA level, Gleason score, comorbidities) and information about therapy and disease progression were collected at the time of study inclusion and subsequently at six-month intervals. According to the non-interventional study design, only recommendations were made for enrollment, course and discontinuation of AS. The final therapeutic decision rested with treating physicians.

Results

Overall, 2957 patients were enrolled, of whom 468 (15.8%) received AS. The AS-group was characterized by the lowest mean baseline level of PSA (5.8 ng/mL), the highest proportion of patients with a Gleason score <7 (92.5%) and with low-risk tumors (82.5%). The mean follow up was 28.5 months. Up to this time 112 patients had changed treatment strategy (RP:65, RT:30, HT:10, WW:7). On the basis of a separate survey until July 2016, the mean follow up was extended to 66.7 months. By that time treatment strategy had changed in another 87 patients (RP:31, RT:18, HT:8, WW:30). In these two periods the rates of therapy switches per month were RP:2.3, RT:1.1, HT:0,4, WW:0,2 and RP:0.8, RT:0.5, HT:0.2, WW:0.8, respectively. Fifteen AS-patients died, but no tumor related deaths were seen.

Conclusions

The results of HAROW indicate that AS is highly applicable in everyday care since the inclusion criteria were largely respected. The percentage of therapy switches of this health services research study (42.5% in 66.7 months) is comparable to the results from clinical AS-trials. With an increase of the observation period, a higher proportion of patients changed to WW when AS was terminated, and remained on a non-invasive strategy.

Funding

The HAROW study was initiated and conducted by the Foundation of Men's Health and financially supported by Gazprom Germania.