About 40% of all men will develop prostate cancer during their lifetime, with over 65,000 new cases diagnosed annually in Germany [1]. Age is a key risk factor, as most cases occur in men aged 65 or older.
“With robot-guided stereotactic radiosurgery (SBRT), we are now able to treat localized prostate cancer – especially intermediate-risk cases – very effectively in many patients,” says Alexander Muacevic, MD, Director of the European Radiosurgery Center Munich (ERCM).
The completed HYPOSTAT-II trial, involving 464 participants – 249 of whom were treated at the ERCM – confirms that SBRT is well tolerated and associated with high patient satisfaction. Results to date are comparable to those of the PACE trials, whose findings contributed to the inclusion of radiosurgery in the German S3 clinical guidelines (the highest level of evidence-based medical guidelines in Germany) in 2025.
PACE-A compared SBRT (75% using CyberKnife) to radical prostatectomy, the surgical removal of the prostate. The data showed significantly fewer functional side effects, such as incontinence or erectile dysfunction, after radiosurgery compared to surgery [2]. PACE-B demonstrated that SBRT is also a safe and effective treatment option compared to conventional radiation therapy [3].
As an alternative to surgery or conventional radiation (which lasts 7 to 8 weeks with 35 to 40 sessions), this high-precision therapy offers a significantly shortened treatment time of 5 sessions over up to 2 weeks.
Together with the University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, led by principal investigator David Krug and study coordinator Oliver Blanck, the ERCM launched the multicenter HYPOSTAT-III trial in November 2025.
The plan is to treat 175 patients with localized prostate cancer (Gleason Score ≤ 7, PSA < 20 ng/ml, IPSS ≤ 12). Alexander Muacevic adds, “Our goal is to further reduce CyberKnife therapy to just 3 sessions, enabling patients to complete treatment within one week – without compromising safety or tolerability.”
Previous HYPOSTAT studies:
The research project began in 2016 with HYPOSTAT-I, the first study in Germany to explore extreme hypofractionation using a robot-guided linear accelerator for prostate cancer treatment [4]. HYPOSTAT-II followed seamlessly.
[1] Cancer in Germany for 2019/2020, 14th edition, Robert Koch Institute (ed.) and the Society of Epidemiological Cancer Registries in Germany (ed.), Berlin 2023.
https://doi.org/10.25646/11357
[2] van As, N., et al., Radical Prostatectomy Versus Stereotactic Radiotherapy for Clinically Localised Prostate Cancer: Results of the PACE-A Randomised Trial, European Urol. 2024;86:566-576.
https://doi.org/10.1016/j.eururo.2024.08.030
[3] van As, N., et al., Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer, N Engl J Med. 2024;391(15):1413-1425.
https://doi.org/10.1056/NEJMoa2403365
[4] Krug, D., et al., Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial, Strahlenther. Onkol. 2023;199:565-573.