Erfolgreich: Dr. Rurainski Stiftung fördert HYPOSTAT Studie – CyberKnife

One in ten men over 50 in Germany is now diagnosed with prostate cancer. This makes prostate cancer the most common cancer in men. So it's no wonder that several Germany-wide studies are currently evaluating and improving existing and new therapy methods for this type of cancer. The HYPOSTAT study carried out by the University Hospitals Schleswig-Holstein (UKSH) and Frankfurt (KGU), as well as the Saphir Radiosurgery Centers and the European CyberKnife Center Munich-Großhadern dealt precisely with the topic and was able to recruit the planned 85 Complete patient successfully. The HYPOSTAT study was the first and so far only study in Germany to deal with a new form of short-term, high-dose radiosurgery using a robot-assisted linear accelerator for the treatment of prostate cancer, the so-called "CyberKnife". As part of the HYPOSTAT study, the prostate is irradiated with the CyberKnife with particular precision and the total number of individual irradiations is reduced to five sessions within one to two weeks.

The extremely hypofractionated radiosurgery for prostate cancer is not a new treatment concept. This treatment technique has been actively tested in the USA for over 15 years and is based on the assumption that high-dose, short-term radiation therapy for the prostate is biologically more beneficial than conventional fractional radiation therapy. These assumptions are also based on the good results of high-dose brachytherapy from the UKSH, Campus Kiel, since the 1990s. At the beginning of 2019, long-term data on CyberKnife radiosurgery from the USA with over 2,000 patients were published. The 7-year prostate cancer control was 85-95 percent, depending on the risk classification, well below 1 percent acute and well below 3 percent long-term clinically relevant side effects. This is where the biological advantage of radiosurgery over many other conventional radiation techniques seems to be proven to be true. The data from the USA have now led to hypofractionated radiosurgery in prostate cancer being an integral part of the American guidelines, and in Germany the S3 guideline for the treatment of prostate tumors also expressly recommended testing radiosurgery in clinical studies.

In addition to the good results from the USA, recruitment for the first arm of the PACE study from England, which randomly compares radiosurgery with conventionally fractionated radiation therapy and, in another study arm, even directly with surgery, was recently ended. "We are eagerly awaiting the results of more than 850 treated patients in this study, which is very likely to have a significant influence on the guidelines." Jürgen Dunst, Director of the Clinic for Radiation Therapy at the UKSH and the Medical Faculty of the Christian-Albrechts-Universität zu Kiel (CAU) and HYPOSTAT study director. “Unfortunately, we are only at the beginning in Germany, but we can report that all patients were very satisfied in our first study. As expected, the side effects turned out to be low, with a good response to the tumor disease at the same time, ”said Prof. Dunst in agreement with Prof. Dr. Alexander Muacevic from the European CyberKnife Center Munich-Großhadern, co-head of the study for the follow-up study.

The first results of the HYPOSTAT-I study are expected at the end of 2019, as each patient in the study has to achieve a minimum follow-up period of twelve months. In parallel to the evaluation of the HYPOSTAT-I study, a larger study was started which is now also intended to examine the long-term effects of radiosurgery on prostate tumors in Germany. Since this study is identical in concept and treatment to the first study, it was named HYPOSTAT-II and 500 patients are to be included. "The study was approved by the Federal Office for Radiation Protection and the leading ethics committee in Kiel and officially started in Kiel on March 5, 2019, so that we were able to guarantee an almost seamless continuation of radiosurgery for prostate tumors in Germany," says Dr. Oliver Blanck, coordinator of the two HYPOSTAT studies. "In addition, we are now starting the study with five radiosurgery centers in Kiel / Güstrow, Frankfurt, Munich, Berlin and Cologne at the same time in order to evaluate prostate radiosurgery in Germany across the board and in the long term," said Dr. Blanck continues.

Literature:
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Kishan AU, Dang A, Katz AJ, Mantz CA, Collins SP, Aghdam N, Chu FI, Kaplan ID, Appelbaum L, Fuller DB, Meier RM, Loblaw DA, Cheung P, Pham HT, Shaverdian N, Jiang N, Yuan Y, Bagshaw H, Prionas N, Buyyounouski MK, Spratt DE, Linson PW, Hong RL, Nickols NG, Steinberg ML, Kupelian PA, King CR. Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer. JAMA Netw Open. 2019 Feb 1;2(2):e188006.

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