Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
Lead Sponsor:
Mayo Clinic
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
NA
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 canc...
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 sy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2027
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06037863
Start Date
September 19 2023
End Date
December 30 2027
Last Update
November 21 2025
Active Locations (7)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
4
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56001