RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>= 18 years

• Histological confirmation of prostate cancer

• Planned definitive dose radiotherapy to the prostate

⁃ Note: Patients are eligible for enrollment if they are already enrolled or planned for enrollment on another interventional research protocol provided that other study protocol treatment does not require procedures or treatments that would be in conflict with the eligibility or treatment protocols for this study nor, in the judgement of the enrolling physician, affect primary study objectives of this study

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

• Ability to complete questionnaire(s) by themselves or with assistance

• Provide written informed consent

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Minnesota
Mayo Clinic Health System in Albert Lea
RECRUITING
Albert Lea
Mayo Clinic Health Systems-Mankato
RECRUITING
Mankato
Mayo Clinic in Rochester
RECRUITING
Rochester
Wisconsin
Mayo Clinic Health System-Eau Claire Clinic
RECRUITING
Eau Claire
Mayo Clinic Health System-Franciscan Healthcare
RECRUITING
La Crosse
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-09-19
Estimated Completion Date: 2028-09-19
Participants
Target number of participants: 168
Treatments
Active_comparator: Arm I (bladder filling, CT, radiation)
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Experimental: Arm II (bladder emptying, CT, radiation)
Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov