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 (5) 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
RECRUITING
Boston
Pennsylvania
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING
Philadelphia
Other Locations
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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