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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 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.

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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.

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

FieldValue
Enrollment Target 168 participants
Start Date 2023-09-19
Est. Completion 2027-12-30
Phase NA

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT06037863

The ClinicalTrials.gov registry entry for NCT06037863 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,499-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (89% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 4 distinct geographic areas - top geographies include 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.

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