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NCT05804318Recruiting

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
132 (estimated)
First submitted
10 Mar 2023
Start date
13 Apr 2023
Primary completion date
31 Jan 2027
Lead sponsor
Varian, a Siemens Healthineers Company
NCT number
NCT05804318

What you commit to

  • Study type: Interventional
  • Planned participants: 132
  • From 13 Apr 2023 to the primary completion date, 31 Jan 2027
  • 8 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • Patient has node positive prostate cancer.
  • Patient has active inflammatory bowel disease or active collagen vascular disease.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)
Coordinator of this site? Confirm its status
HomburgGermanyRecruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Coordinator of this site? Confirm its status
StuttgartGermanyRecruiting
Hospital Universitario de Navarra
Coordinator of this site? Confirm its status
PamplonaSpainRecruiting
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesActive, not recruiting
Duarte Cancer Center
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
City of Hope Orange County Lennar Foundation Cancer Center
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesActive, not recruiting
Washington University in St. Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.