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NCT06037863 · ClinicalTrials.gov registry record · NA
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
A NA study of Prostate Carcinoma, sponsored by Mayo Clinic.
- Active
- Registry status
- NA
- Development phase
- 168
- Enrollment target
- 7
- Study locations
NCT06037863: Active NA study of Prostate Carcinoma, sponsored by Mayo Clinic.
NCT06037863 is a NA study of Prostate Carcinoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 168 participants, below the 1,499-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (89% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06037863, a NA study of Prostate Carcinoma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 168 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Assessed by the change score of urinary irritative/obstructive scale score from the Expanded Prostate Index Composite (EPIC) or EPIC-26 short form questionnaire and compared between patients treated with an empty bladder and standard bladder filling. A t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- OTHER Questionnaire Administration
- OTHER Best Practice
- OTHER Electronic Health Record Review
- PROCEDURE Imaging Procedure
Study Locations (7)
Minnesota
- Mayo Clinic Health System in Albert Lea - Albert Lea
- Mayo Clinic Health Systems-Mankato - Mankato
- Mayo Clinic in Rochester - Rochester
Wisconsin
- Mayo Clinic Health System-Eau Claire Clinic - Eau Claire
- Mayo Clinic Health System-Franciscan Healthcare - La Crosse
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2023-09-19 |
| Est. Completion | 2027-12-30 |
| Phase | NA |
What the registry record for NCT06037863 still lists
NCT06037863 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 1,499-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT06037863 lists 7 locations in 4 states (Minnesota, Wisconsin, Arizona).
Frequently Asked Questions
What is clinical trial NCT06037863 about?
NCT06037863 is a clinical study titled "Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial". 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 ...
What is the current status of trial NCT06037863?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 168 participants. The study started on 2023-09-19. Estimated completion is 2027-12-30.
What conditions does trial NCT06037863 study?
This clinical trial studies the following conditions: Prostate Carcinoma.
What interventions are being tested in trial NCT06037863?
The interventions under investigation include: Computed Tomography (PROCEDURE), Questionnaire Administration (OTHER), Best Practice (OTHER), Electronic Health Record Review (OTHER), Imaging Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT06037863?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06037863 being conducted?
This trial has 7 study locations across Arizona, Florida, Minnesota, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06037863's enrollment target sits among peer trials
168 20th of 59 higher than 40 of 59 other Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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