Daily adaptive radiation therapy for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of daily adaptive stereotactic body radiation therapy (SBRT) with a focus on sparing the urethra in patients with low to intermediate risk localized prostate cancer. It aims to reduce the incidence of acute urinary side effects as reported by patients using the EPIC-26 questionnaire. The study is designed as a prospective, single-arm, multi-center trial, meaning it will involve multiple locations and will assess outcomes based on patient feedback. Participants will receive individualized treatment plans tailored to their specific prostate cancer characteristics.

Why it matters

Who can join: the full rules

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).

Where it's running

• Duarte Cancer Center
  Duarte, California, United States Recruiting
• City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting
• Klinikum der Landeshauptstadt Stuttgart gKAöR
  Stuttgart, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)
  Homburg, Saarland, Germany Recruiting
• Hospital Universitario de Navarra
  Pamplona, Navarre, Spain Recruiting

Study contacts

• Principal investigator: Jonathan Leeman, MD — Brigham and Women's Hospital
• Study coordinator: Sean Davidson, MASc
• Email: sean.davidson@siemens-healthineers.com
• Phone: 1-437-991-8294

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.