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Clinical Trials in the USA / NCT05804318
Recruiting Not applicable

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

NCT05804318 · tracked via the Priya Life Science USA tracker
Sponsor
Varian, a Siemens Healthineers Company
Phase
Not applicable
Started
2023-04-13
Last updated
2026-09-09

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Daily adaptive SBRT with urethral sparing

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)

Trial sites (8)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05804318 on ClinicalTrials.gov ↗ ← All trials in the USA