Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-120
SponsorJena University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
* low / intermediate risk prostate cancer * prostate volume \< 100 ccm
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Patients receiving ultrahypofractionated radiotherapy
Group B: Retrospective reference cohort
Trial outcomes
Primary outcomes
1
Quality 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)Secondary outcomes
1
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)2
Planning parameters
Dose constraints per organ, Conformity Indices, Quality of adaptive planning
Time frame
for every fraction, total: 5x (1 week)3
Dose constraints
Dose constraints for organs at risk and target volumes per fraction
Time frame
for every fraction, total: 5x (1 week)4
Conformity indices
Conformity indices for target volumes, per fraction
Time frame
for every fraction, total: 5x (1 week)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jena University Hospital
Lead sponsor
Klinikum Stuttgart
Collaborator
University Medical Center Göttingen
Collaborator
Kantonsspital Aarau
Collaborator
Hirslanden Stephanshorn
Collaborator
Radiologische Allianz Hamburg
Collaborator
University Hospital Freiburg
Collaborator
Source ClinicalTrials.gov