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 Type
OBSERVATIONAL
Enrollment
150
Department of Radiotherapy and Radiation Oncology, Jena University Hospital
Jena, Germany
RECRUITINGQuality of Life (EPIC 26)
Expanded Prostate Cancer Index Composite 26 (questionnaire)
Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Toxicity (CTCAE v5.0)
Common Terminology Criteria for Adverse Events v5.0
Time frame: 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
Time frame: for every fraction, total: 5x (1 week)
Dose constraints
Dose constraints for organs at risk and target volumes per fraction
Time frame: for every fraction, total: 5x (1 week)
Conformity indices
Conformity indices for target volumes, per fraction
Time frame: 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
Time frame: for every fraction, total: 5x (1 week)
PSA-value
endpoint: Prostate-specific antigene (PSA)-recurrence free survival
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
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