Trials / Recruiting
RecruitingNCT05804318
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- Varian, a Siemens Healthineers Company · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2023-04-13
- Primary completion
- 2026-07-01
- Completion
- 2031-07-01
- First posted
- 2023-04-07
- Last updated
- 2026-02-05
Locations
7 sites across 3 countries: United States, Germany, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05804318. Inclusion in this directory is not an endorsement.