Adaptive Radiotherapy, Prostate Cancer, Quality of Life
Conditions
Keywords
Adaptive Radiotherapy, Quality of Life, Ultra-hypofractionation
Brief 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. 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.
Interventions
None listed
Sponsors
Jena University Hospital
Klinikum Stuttgart
University Medical Center Göttingen
Kantonsspital Aarau
Hirslanden Stephanshorn
Radiologische Allianz Hamburg
University Hospital Freiburg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (EPIC 26) | longitudinally: before + during RT and during follow up (5 years, at least bi-annually) | Expanded Prostate Cancer Index Composite 26 (questionnaire) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity (CTCAE v5.0) | longitudinally: before + during RT and during follow up (5 years, at least bi-annually) | Common Terminology Criteria for Adverse Events v5.0 |
| Planning parameters | for every fraction, total: 5x (1 week) | Dose constraints per organ, Conformity Indices, Quality of adaptive planning |
| Dose constraints | for every fraction, total: 5x (1 week) | Dose constraints for organs at risk and target volumes per fraction |
| Conformity indices | for every fraction, total: 5x (1 week) | Conformity indices for target volumes, per fraction |
| Quality of adaptive planning | for every fraction, total: 5x (1 week) | Semi-quantitative score to evaluate the quality of the adaptive plan and if revisions would be required |
| PSA-value | longitudinally: before + during RT and during follow up (5 years, at least bi-annually) | endpoint: Prostate-specific antigene (PSA)-recurrence free survival |
| Overall survival | 5 Years | — |
| Recurrence free survival | 5 Years | — |
Countries
Germany
Contacts
CONTACTKlaus Pietschmann, MD. MBa. LLM.
Outcome results
None listed