An observational study in Prostate Cancer, Adaptive Radiotherapy and Quality of Life, sponsored by Jena University Hospital. Recruiting at 1 site in Germany. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Jena University Hospital · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Sep 2027, 17 months after the start.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 17 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Jena University Hospital