Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05804318

Run by

Varian, a Siemens Healthineers Company

People needed

132

Starts

2023-04-13

Expected to finish

2031-07-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient has baseline grade ≥3 GI or GU toxicity
• Patient has had prior overlapping pelvic radiotherapy.
• Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
• Patient has node positive prostate cancer.
• Patient has extracapsular extension (capsular abutment is permitted).
• Patient has active inflammatory bowel disease or active collagen vascular disease.
• Patient cannot undergo prostate MRI.
• Patient cannot undergo prostate fiducial marker placement.
• Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.