Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Adaptive Radiotherapy, Quality of Life. Basic parameters: 18 years — 120 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART
Overview
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.
Primary outcome measures
- Quality of Life (EPIC 26) [Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Radiotherapy and Radiation Oncology, Jena University Hospital — Jena
Identifiers
NCT: NCT06355050 · UKJ-ultraHART