Clinical trial NCT06037863: 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
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 168
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Patient-reported urinary symptoms
timeFrame: Baseline, 3 months, 1 and 2 years post radiation therapy (RT)
Secondary outcomes:
measure: Incidence of physician reported gastrointestinal (GI) and genitourinary (GU) adverse events
timeFrame: At 3 months post-RT
measure: Patient-reported bowel quality of life
timeFrame: At 3 months post-RT
measure: Patient-reported severity of urinary tract symptoms
timeFrame: At 3 months post-RT
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Albert Lea
country: United States
facility: Mayo Clinic Health System in Albert Lea
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health Systems-Mankato
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Eau Claire
country: United States
facility: Mayo Clinic Health System-Eau Claire Clinic
state: Wisconsin
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Bradley J. Stish, M.D.
role: PRINCIPAL_INVESTIGATOR
References: