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HAROW: the first comprehensive prospective observational study comparing treatment options in localized prostate cancer

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Abstract

Purpose

To collect data on primary treatment decision and follow-up in patients with diagnosed, histologically confirmed localized (T1a–T2c/N0/M0) prostate cancer (PCa) for up to 5 years in a prospective observational non-interventional study.

Methods

Patients were non-randomly allocated to one of the five treatment strategies: hormone therapy, active surveillance, radiation, operation, or watchful waiting.

Results

A total of 3169 patients were included by 259 participating sites; 2957 patients had at least one follow-up visit. 54.8 % of tumors at baseline were staged as T1c, 38 % as T2a–T2c, and 7.1 % as T1a or T1b (missing: 0.2 %). 38.9, 32.6 and 26.6 % of patients were classified as low risk, intermediate risk, and high risk according to d’Amico, respectively (missing: 1.8 %). 56.6 % of patients underwent prostatectomy as primary therapy, 16.4 % received radiation, 6.9 % HT, 15.8 and 4.3 % decided for AS or WW. Mean follow-up was 28.4 months. Progression rates were between 8.6 % (RT) and 33.1 % (AS).

Conclusion

Whereas RP remains the main treatment option of localized PCa, active surveillance appears to become an accepted and selectively employed treatment option. Careful selection of patients is documented by the highest proportion of patients with low risk (82.5 %), PSA density <0.2 ng/ml/ml (77.5 %), T1 staging (83.6 %), Gleason score ≤6 (92.5 %), ≤2 positive biopsies (79.4 %), and lowest mean PSA (5.8 ng/ml) in the AS group. The relatively high progression rate in the AS group has to be considered in the context of treatment changes; 71/155 patients had a documented change of treatment and 62 of them with a follow-up period of >3 months.

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Acknowledgments

First and foremost we would like to thank all participating colleagues and patients of HAROW for their additional efforts and their discipline making HAROW possible. The scientific advisory panel—H. Rübben, B. Wullich, D. Schnell, A. Schröder, A. Rollenhagen, and H-J. Fiebrandt—was extremely helpful in setting the frame for HAROW and to monitor its progress and safe course. Likewise, the support of the DGU (German society of urology), the German professional association of urologists (Berufsverband der Deutschen Urologen e.V.) and the federal patient association for prostate cancer (Bundesverband Prostatakrebs Selbsthilfe e.V.) should be emphasized. The detailed analyses and quality control of the study data and the manuscript drafts would not have been possible without the continuing support of the team at the Foundation Men’s Health, in particular B. Schicke, W. Czempiel, E. Mack, and D. Chakkalakal in collaboration with E. Boedefeld, C. Börgermann, and C. Roloff. The study was generously sponsored by Gazprom Germania and facilitated by their former managing director for Germany, Mr. H.-J. Gornig, allowing the Foundation Men’s Health to conduct this study completely independent of particular interests. The CRO CSG, namely Ms. E. Hempel, was extremely instrumental in study conduct and data quality assessment.

Authors contribution

L. Weissbach involved in protocol/project development, acquisition of data, and data analysis and wrote the manuscript. S. Stuerzebecher involved in data analysis and wrote the manuscript. E. Mumperow involved in acquisition of data and edited the manuscript. T. Klotz involved in acquisition of data and edited the manuscript. D. Schnell involved in protocol/project development, acquisition of data, and data analysis and edited the manuscript.

Author information

Authors and Affiliations

  1. Foundation Men’s Health (Stiftung Männergesundheit), Claire-Waldoff-Str. 3, 10117, Berlin, Germany

    Lothar Weissbach, Steffen Stuerzebecher & Dietrich Schnell

  2. Urological Practice, Langenfeld, Germany

    Eberhard Mumperow

  3. Department of Urology, Hospital Weiden, Weiden, Germany

    Theodor Klotz

Authors
  1. Lothar Weissbach
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  2. Steffen Stuerzebecher
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  3. Eberhard Mumperow
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  4. Theodor Klotz
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  5. Dietrich Schnell
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Corresponding author

Correspondence to Lothar Weissbach.

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Conflict of interest

Lothar Weissbach is a member of the expert panel QSR of the AOK federal association WIdO. Steffen Stuerzebecher, Eberhard Mumperow, Theodor Klotz and Dietrich Schnell declare that they have no conflict of interest.

Financial disclosure

Gazprom Germany sponsored the Foundation of Men’s Health by providing an unconditional grant for data collection and data management.

Ethical standard

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Ethics Committee of the State Chamber of Medicine in Bavaria and with the 1964 Helsinki Declaration and its later amendments.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Eberhard Mumperow and Theodor Klotz: On behalf of the investigators of the HAROW study [Hormone therapy (HT), Active surveillance (AS), Radiation (RT), Operation (RP), or Watchful waiting (WW)].

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Weissbach, L., Stuerzebecher, S., Mumperow, E. et al. HAROW: the first comprehensive prospective observational study comparing treatment options in localized prostate cancer. World J Urol 34, 641–647 (2016). https://doi.org/10.1007/s00345-015-1675-4

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  • DOI: https://doi.org/10.1007/s00345-015-1675-4

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