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Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
Sponsor: Mayo Clinic
Summary
This clinical trial evaluates the effects of an empty bladder versus (vs.) a full bladder prior to undergoing a computed tomography (CT) simulation for radiation therapy in patients with prostate cancer. Radiation therapy is a commonly used treatment for men diagnosed with prostate cancer. Prior to initiation of a course of radiotherapy, all patients with prostate cancer undergo a CT simulation that allows for computer-based optimization of radiation dose delivery to the target tissue (i.e., prostate) and simultaneous dose minimization to surrounding normal tissues, such as bladder and rectum. Patients are typically given standard instructions for preparation to present with a reproducible full bladder at the time of CT simulation and for each subsequent radiation treatment appointment. The goal of bladder distension is to displace portions of the bladder and bowel away from the highest dose radiation delivery to the prostate. However, as typical urinary symptoms related to radiotherapy develop during treatment, some patients are unable to reproduce the bladder distention achieved at the time of CT simulation. This can result in increased daily treatment time, sub-optimal reproducibility of patient internal anatomy, and increased stress for patients and radiation therapy staff. This trial will evaluate the effects of an empty bladder vs. a full bladder prior to CT simulation and radiation therapy in patients with prostate cancer and how it effects patient reported outcomes.
Official title: RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2023-09-19
Completion Date
2027-12-30
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Best Practice
Undergo bladder filling prior to CT
Computed Tomography
Undergo CT
Electronic Health Record Review
Ancillary studies
Imaging Procedure
Undergo bladder emptying prior to CT
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
Locations (7)
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States