← Back to Search

Radiation Therapy

Bladder Management for Prostate Cancer Radiotherapy

N/A

Recruiting

Led By Bradley J. Stish, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned definitive dose radiotherapy to the prostate

Histological confirmation of prostate cancer

Must not have

Planned delivery of radiotherapy to pelvic lymph nodes

Significant urinary incontinence that precludes standard bladder filling

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 1 and 2 years post radiation therapy (rt)

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at effects of emptying bladder vs. having a full bladder before radiation therapy for prostate cancer. Patients may experience increased stress and longer treatment times with full bladder.

Who is the study for?

Men over 18 with prostate cancer who can consent, have an ECOG performance status of 0-2, and can fill out questionnaires. They should be set for radiotherapy but not have significant urinary incontinence, bladder metastases, use catheters, need pelvic lymph node radiation or brachytherapy, or had prior pelvic radiotherapy above 5 Gy.

What is being tested?

The RELIEF trial is testing whether having an empty or full bladder during CT simulation affects the treatment experience for prostate cancer patients receiving radiation therapy. It looks at how this impacts patient comfort and the precision of targeting the tumor while sparing normal tissues.

What are the potential side effects?

Radiation therapy may cause side effects like skin irritation near treated areas, fatigue, urinary symptoms such as increased frequency or urgency to urinate and bowel changes including diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for targeted radiation therapy to my prostate.

Select...

My prostate cancer has been confirmed through a biopsy.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for radiation therapy targeting my pelvic lymph nodes.

Select...

I have severe urinary incontinence that prevents normal bladder filling.

Select...

My prostate cancer has spread to my bladder.

Select...

My prostate was exposed to more than 5 Gy of radiation.

Select...

I am scheduled for a specific radiation treatment for my prostate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 1 and 2 years post radiation therapy (rt)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 1 and 2 years post radiation therapy (rt)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 1 and 2 years post radiation therapy (rt) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-reported urinary symptoms

Secondary study objectives

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

Patient-reported bowel quality of life

Patient-reported severity of urinary tract symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (bladder emptying, CT, radiation)Experimental Treatment5 Interventions

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

Group II: Arm I (bladder filling, CT, radiation)Active Control5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Imaging Procedure

2003

N/A

~70