RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 168
- Locations
- 12
- Primary Endpoint
- Patient-reported urinary symptoms
Study Overview
Brief 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.
Detailed Description
PRIMARY OBJECTIVE:
I. To determine whether an empty bladder during radiation therapy delivery for prostate cancer is non-inferior to standard bladder filling for change in patient-reported urinary symptoms 3 months post-treatment.
SECONDARY OBJECTIVES:
I. To evaluate whether an empty bladder during radiation therapy delivery for prostate cancer is non-inferior to standard bladder filling for patient-reported bowel symptoms and patient-reported severity of urinary symptoms 3 months post-treatment.
II. To compare physician-assessed genitourinary and gastrointestinal Common Terminology Criteria for Adverse Events (CTCAE) toxicity related to radiation therapy in patients treated with a full versus an empty bladder 3 months post-treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Arm I (bladder filling, CT, radiation)
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Best Practice (Other)
Arm I (bladder filling, CT, radiation)
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Computed Tomography (Procedure)
Arm I (bladder filling, CT, radiation)
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Electronic Health Record Review (Other)
Arm I (bladder filling, CT, radiation)
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Questionnaire Administration (Other)
Arm I (bladder filling, CT, radiation)
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Radiation Therapy (Radiation)
Arm II (bladder emptying, CT, radiation)
Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Computed Tomography (Procedure)
Arm II (bladder emptying, CT, radiation)
Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Electronic Health Record Review (Other)
Arm II (bladder emptying, CT, radiation)
Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Imaging Procedure (Procedure)
Arm II (bladder emptying, CT, radiation)
Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Questionnaire Administration (Other)
Arm II (bladder emptying, CT, radiation)
Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
Intervention: Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Patient-reported urinary symptoms
Time Frame: Baseline, 3 months, 1 and 2 years post radiation therapy (RT)
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.
Secondary Outcomes
- Patient-reported bowel quality of life(At 3 months post-RT)
- Incidence of physician reported gastrointestinal (GI) and genitourinary (GU) adverse events(At 3 months post-RT)
- Patient-reported severity of urinary tract symptoms(At 3 months post-RT)
Investigators
Bradley (Brad) Stish
Principal Investigator
Mayo Clinic