Hypo-fractionated SBRT for localized prostate cancer : a German bi-center single treatment group feasibility trial

  • Background: For prostate cancer treatment, treatment options with minimal side effects are desired. External beam radiation therapy (EBRT) is non-invasive, standard of care and delivered in either conventional fractionation over 8 weeks or with moderate hypo-fractionation over about 5 weeks. Recent advances in radiotherapy technology have made extreme hypo-fractionated stereotactic body radiation therapy (SBRT) of prostate cancer feasible, which has not yet been introduced as a standard treatment method in Germany. Initial results from other countries are promising, but long-term results are not yet available. The aim of this study is to investigate feasibility and effectiveness of SBRT for prostate cancer in Germany. Methods/design: This German bi-center single group trial (HYPOSTAT) is designed to evaluate feasibility and effectiveness, as measured by toxicity and PSA-response, respectively, of an extreme hypo-fractionated SBRT regimen with five fractions of 7 Gy in treatment of localized low and intermediate risk prostate cancer. The target volume includes the prostate with or without the base of seminal vesicles depending on risk stratification and uncertainty margins that are kept at 3–5 mm. SBRT treatment is delivered with the robotic CyberKnife system, which was recently introduced in Germany. Acute and late toxicity after one year will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE v. 4.0), Radiation Therapy Oncology Group (RTOG) and International Prostate Symptom Score (IPSS) Scores. The quality of life will be assessed before and after treatment with the EORTC QLQ C30 questionnaire. Hypothesizing that the proportion of patients with grade 2 side effects or higher is less or equal than 2.8%, thus markedly lower than the standard EBRT percentage (17.5%), the recruitment target is 85 patients. Discussion: The HYPOSTAT trial aims at demonstrating short term feasibility of extreme hypo-fractioned SBRT for the treatment of prostate cancer and might be used as the pilot study for a multi-center multi-platform or for randomized-controlled trials comparing conventional radiotherapy with SBRT for localized prostate cancer in the future. The study concept of patient enrollment, follow up and evaluation by multiple public university clinics and actual patient treatment in dedicated private radiosurgery practices with high-tech radiation equipment is unique for clinical trials. Study status: The study is ongoing and currently recruiting patients. Trial registration: Registration number: NCT02635256 (clinicaltrials.gov). Registered 8 December 2015

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Author:Ping Jiang, Katja Krockenberger, Reinhard Vonthein, Jane Tereszczuk, Arne Schreiber, Sebastian Liebau, Stefan Huttenlocher, Detlef Imhoff, Panagiotis BalermpasORCiDGND, Christian Keller, Kathrin Dellas, René Baumann, Claus RödelORCiDGND, Guido Hildebrandt, Klaus-Peter Jünemann, Alex S. Merseburger, Alan Katz, Andreas Ziegler, Oliver Blanck, Jürgen Dunst
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/28821268
Parent Title (English):Radiation oncology
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Year of Completion:2017
Date of first Publication:2017/08/18
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2018/06/19
Tag:Clinical trial; CyberKnife; Extreme hypo-fractionation; Localized prostate cancer; Robotic Radiosurgery; Stereotactic body radiation therapy
Issue:1, Art. 138
Page Number:7
First Page:1
Last Page:7
Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 4.0