Tests daily adaptive radiation with urethral sparing for prostate cancer
Tests adjustable daily radiation that spares the urethra in adults with localized prostate cancer.
Plain-language title generated from the registry record
Registry title: Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
Key facts
- Where
- Homburg and Stuttgart, GermanySee the 2 sites
Where in Germany
- Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)Homburg, GermanyTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Varian, a Siemens Healthineers Company
- Trial code
- NCT05804318
- Record updated
- 9 September 2026
- Original description
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.Read full original descriptionShow less
Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.
Inclusion: Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven; Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy; AUA/IPSS score is ≤ 15; ECOG performance status is ≤2 (or Karnofsky score is ≥60%); Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion); Patient has the ability to complete required patient questionnaires; Patient age ≥ 18 years (or greater than the local age of majority); Patient has the ability to understand and the willingness to sign a written informed consent document.
Exclusion: Patient has had prior overlapping pelvic radiotherapy; Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation; Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed); Patient has node positive prostate cancer; Patient has active inflammatory bowel disease or active collagen vascular disease; Patient has baseline grade ≥3 GI or GU toxicity; Patient has extracapsular extension (capsular abutment is permitted); Patient cannot undergo prostate MRI; Patient cannot undergo prostate fiducial marker placement.