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Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Duarte Cancer Center
RECRUITING
Duarte
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
Massachusetts
Brigham and Women's Hospital
ACTIVE_NOT_RECRUITING
Boston
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Pennsylvania
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING
Philadelphia
Other Locations
Germany
Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)
RECRUITING
Homburg
Spain
Hospital Universitario de Navarra
RECRUITING
Pamplona
Contact Information
Primary
Sean Davidson, MASc
sean.davidson@varian.com
1-437-991-8294
Backup
Claire McCann, PhD
claire.mccann@varian.com
Time Frame
Start Date: 2023-04-13
Estimated Completion Date: 2031-07
Participants
Target number of participants: 132
Treatments
Experimental: Adaptive SBRT with Urethral Sparing
Daily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra.
Related Therapeutic Areas
Sponsors
Leads: Varian, a Siemens Healthineers Company

This content was sourced from clinicaltrials.gov

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