Prostate CancerHYPOSTAT-IINCT03795337
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)
A study testing Hypofractionated Radiosurgery in people with Prostate Cancer, run by University Hospital Schleswig-Holstein at 8 sites in Germany.
Trial summary
Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible. Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the… Read more about this study
- Who is it for?
- Ages 60 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
- 475 participants
- Where
- 8 sitesGermany
- Study dates
- 5 Mar 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
- Gleason-grade ≤7
- Guideline-based staging
- Age ≥ 60 years
- PSA < 15 ng / ml
- Volume of the prostate < 80 cm³
- IPSS-Score ≤ 12
- Written informed consent
Who cannot join
- Age ≤ 60 years
- History of prior pelvic radiotherapy
- Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
- Immunosuppressive therapy
- Relevant comorbidity thought to adversely affect treatment compliance,
- Legal incapacity or lack of informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Charité Berlin, Department of Radiation Oncology and Radiotherapy (CVK)
Berlin, 13353
University Medical Center Cologne, Department of Radiation Oncology, Cyberknife- and Radiotherapy
Cologne, 50937
CyberKnife Centrum Mitteldeutschland
Erfurt, 99089
Saphir Radiosurgery Center Frankfurt am Main
Frankfurt am Main, 60528
University Hospital Frankfurt, Department of Radiation Therapy and Oncology
Frankfurt am Main, 60590
Saphir Radiosurgery Center Northern Germany
Kiel, 24105
University Medical Center Schleswig-Holstein
Kiel, 24105
European Cyberknife Center Munich
Munich, 81377
About this study
Official title: Hypofractionated Radiosurgery for Localised Prostate Cancer
Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.
Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.
Read the detailed description
Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).
Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated Radiosurgery
- Keywords
- Hypofractionation, Prostate Cancer, Radiotherapy, long-term toxicity
- 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 | 5 fractions with 7 Gy, total dose 35 Gy Receives: Radiation: Hypofractionated Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Measured: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
Secondary outcomes (4)
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
Measured: 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
Prostate Specific Antigen (PSA)
Measured: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
International Prostate Symptom Score (IPSS)
Measured: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
EORTC Quality of Life Questionnaire (QLQ) C30
Measured: At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start5 Mar 2019
- Primary completion4 Mar 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck, Saphir Radiosurgery Center Northern Germany
- Responsible party
- Principal investigator, Juergen Dunst, Prof., University Hospital Schleswig-Holstein
- Investigators
- Juergen Dunst, Prof., Principal investigator, University Hospital Schleswig-HolsteinAlexander Muacevic, Prof., Principal investigator, European CyberKnife Center Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795337
- Sponsor's protocol ID
- ZKS-121-08
- Other IDs
- ARO-2018-4
- Acronym
- HYPOSTAT-II
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2018
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiosurgery for Localised Prostate Cancer
- ClinicalTrials.gov ID
- NCT03795337
- Acronym / sponsor ID
- HYPOSTAT-II / ZKS-121-08
- Conditions
- Prostate Cancer
- Keywords
- Hypofractionation, Prostate Cancer, Radiotherapy, long-term toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 475 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Luebeck, Saphir Radiosurgery Center Northern Germany
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jan 2019 (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 has been investigated in a few trials and appears to be safe and feasible.
Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.
Detailed description
Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).
Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter 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 Radiosurgery5 fractions with 7 Gy, total dose 35 Gy |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
- Gleason-grade ≤7
- Guideline-based staging
- Age ≥ 60 years
- PSA < 15 ng / ml
Key exclusion criteria (6 listed)
- Age ≤ 60 years
- History of prior pelvic radiotherapy
- Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
- Immunosuppressive therapy
- Relevant comorbidity thought to adversely affect treatment compliance,
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
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score
Time frame: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy
4 secondary outcomes
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports.
Time frame: 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
Prostate Specific Antigen (PSA)
Time frame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
International Prostate Symptom Score (IPSS)
Time frame: At the time of inclusion; 4-6 weeks after radiotherapy; 3, 6-9, 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
EORTC Quality of Life Questionnaire (QLQ) C30
Time frame: At the time of inclusion; 12-15 months after radiotherapy thereafter annually for 4 years after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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. This study is not recruiting at the moment.
Juergen Dunst, Prof. principal investigator
University Hospital Schleswig-Holstein
Alexander Muacevic, Prof. principal investigator
European CyberKnife Center Munich
8 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 8 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 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late toxicity measured with Radiation Therapy Oncology Group-(RTOG)-Score (time frame: 3, 6-9, 12-15 months and thereafter annually for 4 years after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.