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

Prostate Carcinoma Clinical Trial

Official title:

RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037863
• Other study ID #: RELIEF
• Secondary ID: NCI-2023-06451GM
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: September 19, 2028

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: September 19, 2028
• Est. primary completion date: September 19, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Other:
• Best Practice
Undergo bladder filling prior to CT

Procedure:
• Computed Tomography
Undergo CT

Other:
• Electronic Health Record Review
Ancillary studies

Procedure:
• Imaging Technique
Undergo bladder emptying prior to CT

Other:
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation Therapy
Undergo radiation therapy

Locations

Country	Name	City	State
United States	Mayo Clinic Health System in Albert Lea	Albert Lea	Minnesota
United States	Mayo Clinic Health System-Eau Claire Clinic	Eau Claire	Wisconsin
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic Health System-Franciscan Healthcare	La Crosse	Wisconsin
United States	Mayo Clinic Health Systems-Mankato	Mankato	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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%.	At 3 months post-RT
Secondary	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.	At 3 months post-RT
Secondary	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.	At 3 months post-RT

External Links

•   Mayo Clinic Clinical Trials