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Clinical trialNCT06037863Active, not recruitingInterventional

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

SponsorMayo ClinicEnrollment168Prostate Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 Sept 2023
Primary completion
30 Dec 2027
Completion
30 Dec 2027
Last update posted
23 Feb 2026
Registered enrollment
168
Registry id
NCT06037863

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.