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

Running, not enrolling · Not applicable

Conditions studied: Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT06037863

Run by

Mayo Clinic

People needed

168

Starts

2023-09-19

Expected to finish

2027-12-30

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Planned delivery of radiotherapy to pelvic lymph nodes
• Planned brachytherapy treatment of the prostate
• Significant urinary incontinence that precludes standard bladder filling
• Evidence of direct bladder extension or bladder wall metastases from prostate cancer
• Used indwelling or intermittent urinary catheterization at baseline
• Prior pelvic radiotherapy such that any portion of the prostate received > 5 Gy

Where it is running

• 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

Full record on ClinicalTrials.gov

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