TY  - JOUR
A1  - Jiang, Ping
A1  - Krockenberger, Katja
A1  - Vonthein, Reinhard
A1  - Tereszczuk, Jane
A1  - Schreiber, Arne
A1  - Liebau, Sebastian
A1  - Huttenlocher, Stefan
A1  - Imhoff, Detlef
A1  - Balermpas, Panagiotis
A1  - Keller, Christian
A1  - Dellas, Kathrin
A1  - Baumann, René
A1  - Rödel, Claus
A1  - Hildebrandt, Guido
A1  - Jünemann, Klaus-Peter
A1  - Merseburger, Alex S.
A1  - Katz, Alan
A1  - Ziegler, Andreas
A1  - Blanck, Oliver
A1  - Dunst, Jürgen
T1  - Hypo-fractionated SBRT for localized prostate cancer : a German bi-center single treatment group feasibility trial
T2  - Radiation oncology
N2  - 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
KW  - Clinical trial
KW  - Localized prostate cancer
KW  - Extreme hypo-fractionation
KW  - Robotic Radiosurgery
KW  - Stereotactic body radiation therapy
KW  - CyberKnife
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/46746
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-467465
SN  - 1748-717X
N1  - 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.
VL  - 12
IS  - 1, Art. 138
SP  - 1
EP  - 7
PB  - BioMed Central
CY  - London
ER  -