Prostate CancerHYPOSTAT-IIINCT06914544
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
A study testing Hypofractionated Radiosurgery in people with Prostate Cancer, run by University Hospital Schleswig-Holstein at 6 sites in Germany.
Trial summary
Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypofractionated Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 6 sitesGermany
- Study dates
- 10 Dec 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
- Gleason-grade ≤7, ISUP Grade Group 1-3
- Guideline-based staging
- Age ≥ 18 years
- PSA < 20 ng/ml
- Volume of the prostate < 80 cm³
- IPSS-Score ≤ 12
- Written informed consent
Who cannot join
- History of prior pelvic radiotherapy
- Previous transurethral resection, laser enucleation or prostate ablation
- Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
- Relevant comorbidity thought to adversely affect treatment compliance
- Legal incapacity or lack of informed consent
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 4 recruiting
- Recruiting
CyberKnife Centrum Mitteldeutschland
Erfurt, Thuringia, 99089
Hans-Ulrich Herold, MD, +4936178172310, Hans-Ulrich.Herold@ckcm.de
Hans-Ulrich Herold, MD
- Recruiting
Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, Hesse, 60528
Christian Arnold, MD, +496967735910, arnold@saphir-rc.com
Christian Arnold, MD
- Suspended
University Hospital Frankfurt
Frankfurt am Main, Hesse, 60528
- Active, not recruiting
Saphir Radiosurgery Center Norther Germany
Kiel, Schleswig-Holstein, 24105
- Recruiting
University Medical Center Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
Stefan Huttenlocher, MD, +494312398990, stefan.huttenlocher@uksh.de
David Krug, MD
- Recruiting
European Radiosurgery Center Munich
Munich, Hesse, 81377
Alexander Muacevic, MD, +49894523360, alexander.muacevic@erc-munich.com
Alexander Muacevic, MD
About this study
Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.
Read the detailed description
Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.
Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated Radiosurgery
- Keywords
- Prostate Cancer, SBRT, CyberKnife, Radiosurgery, HYPOSTAT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RadiosurgeryRadiation
Image-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiosurgery | Experimental | 3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 Gy Receives: Radiation: Hypofractionated Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
GU and GI Toxicity
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Measured: 12-15 months after radiotherapy
Secondary outcomes (5)
Acute toxicity
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Measured: Through study completion
PSA
Prostate Specific Antigen (PSA)
Measured: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
IPSS
International Prostate Symptom Score (IPSS) on a scale 0-35 with lower being better
Measured: Screening and 3, 6-9 and 12-15 months after radiotherapy
Quality of Life Score
EORTC Quality of Life Questionnaire (QLQ) C30 on a scale 0-100 with higher being better
Measured: At the time of inclusion and 12-15 months after radiotherapy
Decision Regret Score
Decision Regret Score on a scale 0-100 with lower being lower regret
Measured: At the time of inclusion and 12-15 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start10 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck
- Responsible party
- Sponsor
- Investigators
- David Krug, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914544
- Sponsor's protocol ID
- ARO-2024-3
- Other IDs
- DRKS00036292
- Acronym
- HYPOSTAT-III
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krug D, Imhoff D, Haidenberger A, Hessler N, Schafer J, Huttenlocher S, Chatzikonstantinou G, Furweger C, Ramm U, Konig IR, Chun F, Staehler M, Rodel C, Muacevic A, Vonthein R, Dunst J, Blanck O. Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial. Strahlenther Onkol. 2023 Jun;199(6):565-573. doi: 10.1007/s00066-023-02044-2. Epub 2023 Feb 9.
PubMed 36757424
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)
- ClinicalTrials.gov ID
- NCT06914544
- Acronym / sponsor ID
- HYPOSTAT-III / ARO-2024-3
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, SBRT, CyberKnife, Radiosurgery, HYPOSTAT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.
Detailed description
Experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 Gy (total application rate of 28.5-31.5 Gy) based on risk grading.
Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiosurgery | Experimental | Radiation: Hypofractionated Radiosurgery3 fractions with 9.5-10.5 Gy, total dose 28.5-31.5 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)
- Gleason-grade ≤7, ISUP Grade Group 1-3
- Guideline-based staging
- Age ≥ 18 years
- PSA < 20 ng/ml
Key exclusion criteria (5 listed)
- History of prior pelvic radiotherapy
- Previous transurethral resection, laser enucleation or prostate ablation
- Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)
- Relevant comorbidity thought to adversely affect treatment compliance
- Legal incapacity or lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated RadiosurgeryImage-guided stereotactic Linac based RT preferable with "dedicated radiosurgery system" such as CyberKnife | Radiation | Hypofractionated Radiosurgery |
Primary outcome
GU and GI Toxicity
Time frame: 12-15 months after radiotherapy
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
5 secondary outcomes
Acute toxicity
Time frame: Through study completion
PSA
Time frame: At the time of inclusion and 1, 3, 6-9 and 12-15 months after radiotherapy
IPSS
Time frame: Screening and 3, 6-9 and 12-15 months after radiotherapy
Quality of Life Score
Time frame: At the time of inclusion and 12-15 months after radiotherapy
Decision Regret Score
Time frame: At the time of inclusion and 12-15 months after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 36757424Krug D, Imhoff D, Haidenberger A, Hessler N, Schafer J, Huttenlocher S, Chatzikonstantinou G, Furweger C, Ramm U, Konig IR, Chun F, Staehler M, Rodel C, Muacevic A, Vonthein R, Dunst J, Blanck O. Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial. Strahlenther Onkol. 2023 Jun;199(6):565-573. doi: 10.1007/s00066-023-02044-2. Epub 2023 Feb 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Krug, MD principal investigator
University Hospital Schleswig-Holstein
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiosurgery in people with Prostate Cancer, run by University Hospital Schleswig-Holstein at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver Blanck, PhD (+4943150026666, oliver.blanck@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GU and GI Toxicity (time frame: 12-15 months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.