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

NCT06037863 | Active Not Recruiting

• 4 other identifiers: RELIEFNCI-2023-06451GMROR235223-005799
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 7

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Patient-reported urinary symptoms

  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.

  Baseline, 3 months, 1 and 2 years post radiation therapy (RT)

Secondary Outcomes (3)

• Incidence of physician reported gastrointestinal (GI) and genitourinary (GU) adverse events

  At 3 months post-RT

• Patient-reported bowel quality of life

  At 3 months post-RT

• Patient-reported severity of urinary tract symptoms

  At 3 months post-RT

Study Arms (2)

Arm I (bladder filling, CT, radiation)

ACTIVE COMPARATOR

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.

Other: Best Practice; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Questionnaire Administration; Radiation: Radiation Therapy

Arm II (bladder emptying, CT, radiation)

EXPERIMENTAL

Patients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study.

Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Imaging Procedure; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (bladder filling, CT, radiation); Arm II (bladder emptying, CT, radiation)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm I (bladder filling, CT, radiation); Arm II (bladder emptying, CT, radiation)

Best Practice OTHER

Undergo bladder filling prior to CT

Also known as: standard of care, standard therapy

Arm I (bladder filling, CT, radiation)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Computerized Tomography (CT) scan

Arm I (bladder filling, CT, radiation); Arm II (bladder emptying, CT, radiation)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (bladder filling, CT, radiation); Arm II (bladder emptying, CT, radiation)

Imaging Procedure PROCEDURE

Undergo bladder emptying prior to CT

Also known as: Diagnostic Imaging Technique, Image Type, Imaging, Imaging (procedure), Imaging Procedures, Imaging Technique, imaging type, IMAGING_METHOD, imaging_type, Medical Imaging, Type of imaging

Arm II (bladder emptying, CT, radiation)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (7)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; X-Rays; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation, Ionizing; Therapeutics

Study Officials

• Bradley J. Stish, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (7)