NCT06037863

Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial

Active, enrolled NA Last updated 23 February 2026

What this trial tests

NA trial testing Best Practice in Prostate Carcinoma in 168 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 September 2023

Primary endpoint
30 December 2027

30 December 2027

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	19 September 2023
Primary completion	30 December 2027
Estimated completion	30 December 2027
Sites	7 locations across United States

Drugs / interventions tested

• Best Practice
• Computed Tomography
• Electronic Health Record Review
• Imaging Procedure
• Questionnaire Administration
• Radiation Therapy — full drug profile →

Conditions studied

• Prostate Carcinoma — all drugs for Prostate Carcinoma →

Sponsor

Mayo Clinic

Who can join

18 and older, male only, with Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.