RECRUITING Not applicable ClinicalTrials.gov

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Sponsor: Varian, a Siemens Healthineers Company • ClinicalTrials.gov ID: NCT05804318

Registry updated: 2026-09-09

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

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.

Interventions

Daily adaptive SBRT with urethral sparing (Device)
The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.

Eligibility criteria

Inclusion Criteria: 1. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven. 2. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy. 3. AUA/IPSS score is ≤ 15. 4. ECOG performance status is ≤2 (or Karnofsky score is ≥60%). 5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion). 6. Patient has the ability to complete required patient questionnaires. 7. Patient age ≥ 18 years (or greater than the local age of majority). 8. Patient has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patient has baseline grade ≥3 GI or GU toxicity 2. Patient has had prior overlapping pelvic radiotherapy. 3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation. 4. Patient has node positive prostate cancer. 5. Patient has extracapsular extension (capsular abutment is permitted). 6. Patient has active inflammatory bowel disease or active collagen vascular disease. 7. Patient cannot undergo prostate MRI. 8. Patient cannot undergo prostate fiducial marker placement. 9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

Conditions

Prostate Cancer

Locations

Duarte Cancer Center — Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Washington University in St. Louis — St Louis, Missouri, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Klinikum der Landeshauptstadt Stuttgart gKAöR — Stuttgart, Baden-Wurttemberg, Germany
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital) — Homburg, Saarland, Germany
Hospital Universitario de Navarra — Pamplona, Navarre, Spain

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment