Back to Search Results- Recruiting
- Treatment
- Interventional
- Randomized
- Other & Procedure
- Mayo Clinic
- 18 Years -
Study Purpose
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.
Intervention
Other : Best Practice
Procedure : Computed Tomography
Other : Electronic Health Record Review
Procedure : Imaging Procedure
Other : Questionnaire Administration
Radiation : Radiation Therapy
Eligibility Requirements
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
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
Recruiting status
Recruiting
Estimated enrollment
168
Study start date
Sep 19, 2023
Study end date
Sep 19, 2028
Last updated
Mar 22, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Other & Procedure
Study phase
NA
Allocation
Randomized
Sponsor:
Mayo Clinic
Collaborator:
N/A
Investigator:
Bradley J. Stish, M.D.
N/A
NCT06037863
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