First Interim Results of HAROW Study

Until the end of October 2009, HAROW recruited more than 1,000 men who were newly diagnosed with prostate cancer. The results of the first interim evaluation are now available.

HAROW is a non-interventional, prospective health care study, i.e. it observes and documents under ordinary, everyday conditions without exerting influence on the type and implementation of the therapy. It is primarily practicing urologists and their patients who are addressed in this study. The results of the so-called medical routine and/or everyday health care are ascertained and evaluated. In contrast to classic clinical studies, HAROW also includes and assesses the information provided by the patients themselves (patient-reported outcomes, PROs). These PROs include specifically the quality of life of those who are affected, their individual experiences with the disease, and the doctor-patient relationship. Ideally, the HAROW data will serve as the basis for a new direction in doctors’ recommendations (guideline) and for health care directives. Another important objective of the study is to comprehensively ascertain any and all costs associated with the disease.
Prof. Dr. med. Lothar Weißbach is the scientific supervisor, and a scientific advisory board accompanies the study.
HAROW is supported by Gazprom Germania. The company, thus, not only subsidizes sports and culture, but for the first time ever, also a medical project.

First Interim Results

The data of 547 participants who had been registered by March 12, 2009, were included in the first interim evaluation. The average age of the patients was 67.5 years; the majority of these patients had 1-2 concomitant diseases at the beginning of the study, most often diabetes mellitus. As far as comorbidity is concerned, the HAROW cohort can, thus, be considered to be representative for the respective age group.
The most frequent tumor category with 42 % was T1c (those are tumors which are only verifiable through needle biopsy).
The so-called Gleason Score is a scale for cytodifferentiation. It ranges from 5 to 10. The higher the Gleason Score, the faster the tumors grow and the more aggressive they are estimated to be. More than half of the HAROW patients had a Gleason Score of ≤ 6, 17 % had 7a, and 6 % had each 7b as well as 8-10.
In the study, the median PSA value amounted to 10.0 ng/ml whereas most patients (51 %) ranged between 4 ng/ml and 10 ng/ml. 5 % of the patients exhibited a value of more than 20 ng/ml.
As to risk stratification which is derived from these parameters, 61 % of the participants belonged to the so-called low risk category which is characterized by an outstanding prognosis: In patients with a tumor belonging to this risk category, no clinically relevant progression is to be expected over the long term.

Treatment

The decision whether to opt for surgery or radiation was reached after an average period of 30 days. 47 % decided in favor of a surgery (RP), 9 % in favor of AS, and 7 % each in favor of radiation, hormonal therapy, or a combined therapy (please see the diagram).
On average, radiation patients are 5 years older while patients with hormonal therapy are 10 years older than those patients who are operated.

Patient Satisfaction

Representative for the sector patient-reported outcomes shall be two examples from the categories “patient satisfaction, empathy.” To the question as to whether the physician explained to the patient everything in a comprehensive and understandable manner, 81 % responded with “is always true,” and another 16 % responded with “is often true.” The patients seemed to be highly satisfied with the professional explanations. To the question as to whether the physician helped the patient cope with the disease, 65 % responded with “is always true,” and another 25 % responded with “is often true.” This was also widely accepted. However, the responses also indicate that there are specific expectations towards the urologist to provide more comprehensive support in coping with the disease. Recommendations for a specific lifestyle (nutrition, relaxation, sports and exercise with prostate cancer) might be appropriate and suitable in balancing this deficit.