Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
Recruiting · NCT05804318 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Daily adaptive SBRT with urethral sparing
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
8 locations listed across 4 US states.
- 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
- Hospital Universitario de Navarra - Pamplona, Navarre, Spain
- Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital) - Homburg, Saarland, Germany