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

Primary Purpose

Prostate Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Computed Tomography
Electronic Health Record Review
Imaging Technique
Questionnaire Administration
Radiation Therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Mayo Clinic in Arizona
  • Mayo Clinic in FloridaRecruiting
  • Mayo Clinic Health System in Albert LeaRecruiting
  • Mayo Clinic Health Systems-MankatoRecruiting
  • Mayo Clinic in RochesterRecruiting
  • Mayo Clinic Health System-Eau Claire ClinicRecruiting
  • Mayo Clinic Health System-Franciscan HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (bladder filling, CT, radiation)

Arm II (bladder emptying, CT, radiation)

Arm Description

Patients perform SOC bladder filling and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.

Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%.
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.
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.

Full Information

First Posted
September 7, 2023
Last Updated
September 29, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT06037863
Brief Title
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
Official Title
RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Anticipated)
Primary Completion Date
September 19, 2028 (Anticipated)
Study Completion Date
September 19, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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 5-39 fractions at the discretion of the treating clinician on study. ARM II: Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study. After completion of study intervention, patients are followed up at 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (bladder filling, CT, radiation)
Arm Type
Active Comparator
Arm Description
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.
Arm Title
Arm II (bladder emptying, CT, radiation)
Arm Type
Experimental
Arm Description
Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Undergo bladder filling prior to CT
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Imaging Technique
Other Intervention Name(s)
Diagnostic Imaging Technique, Image Type, Imaging, Imaging (procedure), imaging procedure, Imaging Procedures, imaging type, IMAGING_METHOD, imaging_type, Medical Imaging, Type of imaging
Intervention Description
Undergo bladder emptying prior to CT
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Primary Outcome Measure Information:
Title
Patient-reported urinary symptoms
Description
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.
Time Frame
Baseline, 3 months, 1 and 2 years post radiation therapy (RT)
Secondary Outcome Measure Information:
Title
Incidence of physician reported gastrointestinal (GI) and genitourinary (GU) adverse events
Description
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%.
Time Frame
At 3 months post-RT
Title
Patient-reported bowel quality of life
Description
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.
Time Frame
At 3 months post-RT
Title
Patient-reported severity of urinary tract symptoms
Description
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.
Time Frame
At 3 months post-RT

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley J. Stish, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Jean Claude M. Rwigema, M.D.
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Albert N. Attia, M.D.
Facility Name
Mayo Clinic Health System in Albert Lea
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Timothy F. Kozelsky, M.D.
Facility Name
Mayo Clinic Health Systems-Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ron S. Smith, M.D.
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Bradley J. Stish, M.D.
Facility Name
Mayo Clinic Health System-Eau Claire Clinic
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Zachary C. Wilson, M.D.
Facility Name
Mayo Clinic Health System-Franciscan Healthcare
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Abigail L. Stockham, M.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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