Prostate CarcinomaNCT06037863
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
A study testing Best Practice, Computed Tomography and Electronic Health Record Review in people with Prostate Carcinoma, run by Mayo Clinic at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Best Practice, Computed Tomography and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Sep 2023to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- 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
- Prostate Carcinoma
- Being tested
- Best Practice, Computed Tomography, Electronic Health Record Review, Imaging Procedure, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo bladder filling prior to CT
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Electronic Health Record ReviewOther
Ancillary studies
Imaging ProcedureProcedure or surgery
Also called Diagnostic Imaging Technique, Image Type, Imaging, Imaging (procedure)
Undergo bladder emptying prior to CT
Questionnaire AdministrationOther
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Imaging Procedure; Other: Questionnaire Administration; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Defined as a composite of the hematuria, urinary incontinence, urinary retention, urinary tract pain, urinary frequency, and urinary urgency items from the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0) for the genitourinary toxicities and by a composite of the rectal hemorrhage, diarrhea, and proctitis items from the CTCAE v 5.0 for the gastrointestinal toxicities. The proportion of patients with a grade 2 or higher GU and GI toxicity at 3 months post-RT will be estimated by the number of patients experiencing a grade 2 or higher GU and GI event divided by the total number of evaluable patients, respectively. Comparisons between treatment arms will be made using a Chi-square test with an alpha level of 5%.
Measured: At 3 months post-RT
Patient-reported bowel quality of life
Assessed by the bowel scale score from EPIC-26 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 with a non-inferiority margin of 7 points.
Measured: At 3 months post-RT
Patient-reported severity of urinary tract symptoms
Assessed by International Prostate Symptom Score (IPSS) and t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level with a non-inferiority margin of 4 points.
Measured: At 3 months post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start19 Sep 2023
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley (Brad) Stish, Mayo Clinic
- Investigators
- Bradley J. Stish, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037863
- Sponsor's protocol ID
- GMROR2352
- Other IDs
- 23-005799
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder
- ClinicalTrials.gov ID
- NCT06037863
- Acronym / sponsor ID
- GMROR2352
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (bladder filling, CT, radiation) | Active comparator | Other: Best Practice, Procedure: Computed Tomography, Other: Electronic Health Record Review, Other: Questionnaire Administration, Radiation: Radiation TherapyPatients perform SOC bladder filling and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study. |
| Arm II (bladder emptying, CT, radiation) | Experimental | Procedure: Computed Tomography, Other: Electronic Health Record Review, Procedure: Imaging Procedure, Other: Questionnaire Administration, Radiation: Radiation TherapyPatients perform bladder emptying and then undergo CT and radiation therapy in 2-39 fractions at the discretion of the treating clinician on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- Histological confirmation of prostate cancer
- Planned definitive dose radiotherapy to the prostate
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Ability to complete questionnaire(s) by themselves or with assistance
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo bladder filling prior to CT | Other | Arm I (bladder filling, CT, radiation) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm I (bladder filling, CT, radiation), Arm II (bladder emptying, CT, radiation) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (bladder filling, CT, radiation), Arm II (bladder emptying, CT, radiation) |
| Imaging ProcedureAlso: Diagnostic Imaging Technique, Image Type, Imaging, Imaging (procedure)Undergo bladder emptying prior to CT | Procedure or surgery | Arm II (bladder emptying, CT, radiation) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (bladder filling, CT, radiation), Arm II (bladder emptying, CT, radiation) |
| Radiation TherapyAlso: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, IrradiateUndergo radiation therapy | Radiation | Arm I (bladder filling, CT, radiation), Arm II (bladder emptying, CT, radiation) |
Primary outcome
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.
3 secondary outcomes
Incidence of physician reported gastrointestinal (GI) and genitourinary (GU) adverse events
Time frame: At 3 months post-RT
Patient-reported bowel quality of life
Time frame: At 3 months post-RT
Patient-reported severity of urinary tract symptoms
Time frame: At 3 months post-RT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley J. Stish, M.D. principal investigator
Mayo Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Computed Tomography and Electronic Health Record Review in people with Prostate Carcinoma, run by Mayo Clinic at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported urinary symptoms (time frame: Baseline, 3 months, 1 and 2 years post radiation therapy (RT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.