Dr. Dietrich Schnell, Prof. Dr. Lothar Weißbach, Men S Health Foundation, Berlin, Germany

ABSTRACT

Active surveillance patients in HAROW* – the first comprehensive prospective non-interventional study comparing treatment options in localized prostate cancer

Dr. Dietrich Schnell, Prof. Dr. Lothar Weißbach, Men’s Health Foundation, Berlin, Germany

Introduction and objectives

The optimal therapeutic approach for patients with early localized PCa is still a matter of controversy. This non-interventional “real life” study in patients with newly diagnosed, histologically confirmed localized PCa compared five treatment options: *Hormone therapy, Active surveillance (AS), Radiation therapy, Operation and Watchful waiting (WW). A special focus of this study was on AS patients with regard to selection criteria, course of disease and treatment strategy changes; the data of this subgroup will be presented.

Material and methods

A total of 259 participating sites in Germany (mainly office based urologists) approached all newly diagnosed patients for their interest to participate in the study. Tumor staging, risk stratification, and primary treatment decision were recorded at baseline; further treatment, follow-up diagnostic procedures, progression of disease, and quality of life were documented at regular intervals.

Results

A total of 3,169 patients were enrolled between July 2008 and July 2013. The majority of tumors were staged at baseline as T1c (55%), 37.8 % as T2a-T2c, and 7.1% as T1a or T1b. 54% of patients underwent prostatectomy as primary therapy, 22.7% received hormone therapy, radiation or a combination of both, and in 19.6% doctors and patients decided for a “defensive” treatment strategy of WW or AS, with the majority of these patients (473 patients, 14.9%) in the AS group; 3.7% had “other therapies”. The mean duration of follow for the AS group was 1.84 years. The group was characterized by the lowest mean baseline levels of PSA (5.8 ng/mL), the highest proportions of patients with a Gleason score of ≤6 (93.6%) and a tumor staging of < T1c (84.8%) at baseline. 38.9% of the AS patients had a follow-up biopsy and for 23.3% changes in treatment were documented; 64 patients underwent prostatectomy, 21 received radiation therapy, 10 hormone therapy, and 8 changed to WW (n=7 combination, “other therapy” or not specified). In the majority of cases tumor progression was the reason to change therapy. The progression rate including PSA-DT (<3 years) was 40.4%, excluding PSA-DT as a progression criterion the rate was 28.3% (based on change in clinical stage, number of positive biopsy cores >2 or increase in Gleason score). Subgroups of AS patients with low risk at baseline (according to D’Amico: PSA <10ng/mL, Gleason =6, T1-T2a; n=364) vs patients not fulfilling these criteria (n=109) showed comparable progression rates. Patients on AS showed the lowest incidence of adverse events compared to all other treatment groups. 8 patients on AS died of causes not related to PCa.

Conclusion

The results of HAROW reflect the current practice of German urologists in making primary treatment decisions and changing treatment strategy depending on the further course of PCa.

Author’s affiliation:

Dr. med. Dietrich Schnell

Foundation of Men’s Health

Claire-Waldoff-Straße 3

10117 Berlin

Germany

Phone: +49 30 65 21 26 0

Fax: +49 30 65 21 26 112

Email:

Prof. Dr. med. Lothar Weißbach