ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder

Quick Facts

Study Start:2023-09-19
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06037863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Histological confirmation of prostate cancer
  3. * Planned definitive dose radiotherapy to the prostate
  4. * 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
  5. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  6. * Ability to complete questionnaire(s) by themselves or with assistance
  7. * Provide written informed consent
  1. * Planned delivery of radiotherapy to pelvic lymph nodes
  2. * Planned brachytherapy treatment of the prostate
  3. * Significant urinary incontinence that precludes standard bladder filling
  4. * Evidence of direct bladder extension or bladder wall metastases from prostate cancer
  5. * Used indwelling or intermittent urinary catheterization at baseline
  6. * Prior pelvic radiotherapy such that any portion of the prostate received \> 5 Gy

Contacts and Locations

Principal Investigator

Bradley J. Stish, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Bradley J. Stish, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2023-09-19
Study Completion Date2027-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Carcinoma