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Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

NCT05804318 · Varian, a Siemens Healthineers Company
In plain English

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Official title
Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
About this study
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 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).
Study design
Enrollment target: 132 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-04-13
Estimated completion: 2031-07
Last updated: 2026-02-05
Interventions
Device: Daily adaptive SBRT with urethral sparing
Primary outcomes
  • Patient-reported acute urinary toxicity (90 days after end of SBRT)
Sponsor
Varian, a Siemens Healthineers Company · industry
Contacts & investigators
ContactSean Davidson, MASc · contact · sean.davidson@varian.com · 1-437-991-8294
ContactClaire McCann, PhD · contact · claire.mccann@varian.com
InvestigatorJonathan Leeman, MD · principal_investigator, Brigham and Women's Hospital
InvestigatorJeremy Bredfeldt, PhD · principal_investigator, Brigham and Women's Hospital
All locations (7)
Duarte Cancer CenterRecruiting
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer CenterRecruiting
Irvine, California, United States
Brigham and Women's HospitalActive Not Recruiting
Boston, Massachusetts, United States
Washington University in St. LouisRecruiting
St Louis, Missouri, United States
Fox Chase Cancer CenterActive Not Recruiting
Philadelphia, Pennsylvania, United States
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)Recruiting
Homburg, Saarland, Germany
Hospital Universitario de NavarraRecruiting
Pamplona, Navarre, Spain
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer · TrialPath