Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
NCT ID: NCT06037863
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
168 participants
INTERVENTIONAL
2023-09-19
2027-12-30
Brief Summary
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Detailed Description
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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.
EXPLORATORY OBJECTIVES:
I. To evaluate the differences in dosimetric parameters, using both absolute and relative volumetric measures, between the full bladder and empty bladder patients and correlate with toxicity scores 3 months post-treatment.
II. To compare patient experience questionnaire answers between arms. III. To compare daily treatment evaluations by radiation therapists (RTT) between arms.
IV. To test for moderation of the treatment effect on the primary endpoint by the four stratification factors.
V. To evaluate whether an empty bladder during radiation therapy delivery for prostate cancer is non-inferior to standard bladder filling for patient-reported urinary symptoms at end of therapy (EOT) and severity, function, and bother 3 months post- treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients perform standard of care (SOC) bladder filling and then undergo computed tomography (CT) and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
ARM II: Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.
After completion of study intervention, patients are followed up at 3 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Best Practice
Undergo bladder filling prior to CT
Computed Tomography
Undergo CT
Electronic Health Record Review
Ancillary studies
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
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.
Computed Tomography
Undergo CT
Electronic Health Record Review
Ancillary studies
Imaging Procedure
Undergo bladder emptying prior to CT
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
Interventions
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Best Practice
Undergo bladder filling prior to CT
Computed Tomography
Undergo CT
Electronic Health Record Review
Ancillary studies
Imaging Procedure
Undergo bladder emptying prior to CT
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Bradley (Brad) Stish
Principal Investigator
Principal Investigators
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Bradley J. Stish, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-06451
Identifier Type: REGISTRY
Identifier Source: secondary_id
GMROR2352
Identifier Type: OTHER
Identifier Source: secondary_id
23-005799
Identifier Type: OTHER
Identifier Source: secondary_id
RELIEF
Identifier Type: -
Identifier Source: org_study_id
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