Prostate CancerultraHARTNCT06355050
Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer
An observational study of Prostate Cancer and Adaptive Radiotherapy, run by Jena University Hospital at 1 site in Germany.
Trial summary
In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer, Adaptive Radiotherapy, Quality of Life
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2026to 30 Sep 2032
- Phase
- Observational
- 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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: * low / intermediate risk prostate cancer * prostate volume < 100 ccm
Who may be able to join
- no androgen deprivation therapy within the last 2 months prior to RT
- good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)
- no secondary malignancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiotherapy and Radiation Oncology, Jena University Hospital
Jena
Klaus Pietschmann, MD, +4936419328401, klaus.pietschmann@med.uni-jena.de
Georg Wurschi, MD
About this study
Official title: Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART
In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.
- Conditions
- Prostate Cancer, Adaptive Radiotherapy, Quality of Life
- Keywords
- Adaptive Radiotherapy, Quality of Life, Ultra-hypofractionation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving ultrahypofractionated radiotherapy | Not described | |
| Retrospective reference cohort | reference cohort of patients who underwent normofractionated radiotherapy or moderately hypofractionated radiotherapy earlier. matching 1:1:1 by tumor stage and risk profile (d'Amico) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (EPIC 26)
Expanded Prostate Cancer Index Composite 26 (questionnaire)
Measured: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Secondary outcomes (8)
Toxicity (CTCAE v5.0)
Common Terminology Criteria for Adverse Events v5.0
Measured: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Planning parameters
Dose constraints per organ, Conformity Indices, Quality of adaptive planning
Measured: for every fraction, total: 5x (1 week)
Dose constraints
Dose constraints for organs at risk and target volumes per fraction
Measured: for every fraction, total: 5x (1 week)
Conformity indices
Conformity indices for target volumes, per fraction
Measured: for every fraction, total: 5x (1 week)
Quality of adaptive planning
Semi-quantitative score to evaluate the quality of the adaptive plan and if revisions would be required
Measured: for every fraction, total: 5x (1 week)
PSA-value
endpoint: Prostate-specific antigene (PSA)-recurrence free survival
Measured: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Overall survival
Measured: 5 Years
Recurrence free survival
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2032 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Stuttgart, University Medical Center Göttingen, Kantonsspital Aarau, Hirslanden Stephanshorn, Radiologische Allianz Hamburg, University Hospital Freiburg
- Responsible party
- Principal investigator, Georg Wurschi, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355050
- Sponsor's protocol ID
- UKJ-ultraHART
- Acronym
- ultraHART
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART
- ClinicalTrials.gov ID
- NCT06355050
- Acronym / sponsor ID
- ultraHART / UKJ-ultraHART
- Conditions
- Prostate Cancer, Adaptive Radiotherapy, Quality of Life
- Keywords
- Adaptive Radiotherapy, Quality of Life, Ultra-hypofractionation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Klinikum Stuttgart, University Medical Center Göttingen, Kantonsspital Aarau, Hirslanden Stephanshorn, Radiologische Allianz Hamburg, University Hospital Freiburg
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 9 Apr 2024 (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.
In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving ultrahypofractionated radiotherapy | – | – |
| Retrospective reference cohort | – | –reference cohort of patients who underwent normofractionated radiotherapy or moderately hypofractionated radiotherapy earlier. matching 1:1:1 by tumor stage and risk profile (d'Amico) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * low / intermediate risk prostate cancer * prostate volume < 100 ccm
Key inclusion criteria (3 listed)
- no androgen deprivation therapy within the last 2 months prior to RT
- good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)
- no secondary malignancy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life (EPIC 26)
Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Expanded Prostate Cancer Index Composite 26 (questionnaire)
8 secondary outcomes
Toxicity (CTCAE v5.0)
Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Planning parameters
Time frame: for every fraction, total: 5x (1 week)
Dose constraints
Time frame: for every fraction, total: 5x (1 week)
Conformity indices
Time frame: for every fraction, total: 5x (1 week)
Quality of adaptive planning
Time frame: for every fraction, total: 5x (1 week)
PSA-value
Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Overall survival
Time frame: 5 Years
Recurrence free survival
Time frame: 5 Years
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 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Adaptive Radiotherapy, run by Jena University Hospital at 1 site 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 3 inclusion and 0 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Klaus Pietschmann, MD. MBa. LLM. (00 - 49 03641 - 9-328401, strahlentherapie@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (EPIC 26) (time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)). 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 11 Jun 2026.