Daily adaptive SBRT with urethral sparing: 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.
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Patient-reported acute urinary toxicity — 90 days after end of SBRT Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.
Trial sites (8)
Facility
City
Region
Status
Duarte Cancer Center
Duarte
California
Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine
California
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Active Not Recruiting
Washington University in St. Louis
St Louis
Missouri
Recruiting
Fox Chase Cancer Center
Philadelphia
Pennsylvania
Active Not Recruiting
Klinikum der Landeshauptstadt Stuttgart gKAöR
Stuttgart
Baden-Wurttemberg
Recruiting
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)
Homburg
Saarland
Recruiting
Hospital Universitario de Navarra
Pamplona
Navarre
Recruiting
More Varian, a Siemens Healthineers Company trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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