PREFERE study: Professional society and professional association of German urologists regret stopping funding
Berlin. With regret, the German Society for Urology eV (DGU) and the Professional Association of German Urologists eV (BDU eV) noted today that the sponsors of the PREFERE study on locally limited prostate cancer have decided to fund the study due to insufficient patient recruitment adjust. According to a joint press release by the German Cancer Aid, AOK-Bundesverband, BKK Dachverband, IKK eV, Knappschaft, social insurance for agriculture, forestry and horticulture, Verband der Ersatzkassen eV (vdek) and the Verband der Privaten Gesundheitsversicherung (German Association for Private Health Insurance), the study funding will take effect on December 31 Ended in 2016.
"The medical association of urologists and the professional association of urologists have to state that, despite the greatest efforts of everyone involved, it was not possible to use the PREFERE study to investigate the therapy concepts for locally limited prostate cancer," says DGU General Secretary Prof. Dr. Maurice Stephan Michel. The President of the Professional Association of German Urologists, Dr. Axel Schroeder, emphasizes: “DGU and BDU supported the study commissioned by the Federal Joint Committee (G-BA) in 2013 to examine the effectiveness of treatment strategies, side effects and the effects on quality of life at the highest study level and prostate cancer patients more in the future To enable decision-making certainty in the choice of therapy. "
To this end, the four strategies recommended in the S3 guideline for the treatment of localized prostate cancer with low and early intermediate risk should be prospectively randomized for the first time in the world's largest study on localized prostate cancer. This means that the study participants were randomly assigned to one of the four treatment options: complete surgical removal of the prostate, radiation therapy from outside, radiation from radiation sources permanently placed in the prostate, or active surveillance, in which treatment only started when the disease progressed starts. This so-called randomization minimizes the influence of external factors and allows the highest quality comparison of the four treatment strategies. In order to take patient preferences into account, the participants in the PREFERE study were able to exclude one or a maximum of two of the four treatment options.
Although the PREFERE study was supported by a large alliance of German Cancer Aid, statutory and private health insurance companies, DGU and BDU, the German Society for Radiation Oncology, the German Cancer Society and the Federal Association of Prostate Cancer Self-Help eV, the study objectives regarding the recruitment of the number of participants in the planned time of four years can no longer be achieved. With the discontinuation of funding, the question of the best therapy option for locally limited prostate cancer, also with regard to stress and quality of life, remains unclear.
For the benefit of newly ill men in the future, the DGU and BDU therefore advocate further pursuing the PREFERE study approach with other scientific methods. For example, the therapies chosen based on individual medical advice and self-determined patient decisions could be documented and evaluated in terms of success, stress and quality of life under adapted study conditions. The DGU General Secretary, Prof. Maurice Stephan Michel, who was newly elected in September and BDU President Dr. Axel Schroeder emphasize that both associations consider clarification of this issue to be important and are actively available to advise, detail and support such a changed concept.