Clinical trial · Observational
Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer
Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adaptive Radiotherapy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients receiving ultrahypofractionated radiotherapy
- label
- Retrospective reference cohort
- description
- 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)
Primary outcomes (1)
- measure
- Quality of Life (EPIC 26)
- timeFrame
- longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
- description
- Expanded Prostate Cancer Index Composite 26 (questionnaire)
Secondary outcomes (8)
- measure
- Toxicity (CTCAE v5.0)
- timeFrame
- longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available