NCT06037863Completed
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 168 (actual)
- First submitted
- 7 Sept 2023
- Start date
- 19 Sept 2023
- Primary completion date
- 23 Feb 2026
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT06037863
What you commit to
- Study type: Interventional
- Participants enrolled: 168
- From 19 Sept 2023 to the primary completion date, 23 Feb 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned delivery of radiotherapy to pelvic lymph nodes
- Prior pelvic radiotherapy such that any portion of the prostate received \> 5 Gy
Other illness
- Evidence of direct bladder extension or bladder wall metastases from prostate cancer
Other
- Planned brachytherapy treatment of the prostate
- Significant urinary incontinence that precludes standard bladder filling
- Used indwelling or intermittent urinary catheterization at baseline
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Health System in Albert Lea Coordinator of this site? Confirm its status | Albert Lea | United States | Unknown status |
| Mayo Clinic Health System-Eau Claire Clinic Coordinator of this site? Confirm its status | Eau Claire | United States | Unknown status |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Mayo Clinic Health System-Franciscan Healthcare Coordinator of this site? Confirm its status | La Crosse | United States | Unknown status |
| Mayo Clinic Health Systems-Mankato Coordinator of this site? Confirm its status | Mankato | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.