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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am scheduled for targeted radiation therapy to my prostate.

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My prostate cancer has been confirmed through a biopsy.

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

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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-reported urinary symptoms

Secondary outcome measures

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

Patient-reported bowel quality of life

Patient-reported severity of urinary tract symptoms

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 5-39 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 5-39 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

~2720

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,334 Total Patients Enrolled

33 Trials studying Prostate Cancer

8,234 Patients Enrolled for Prostate Cancer

Bradley J. Stish, M.D.Principal InvestigatorMayo Clinic

2 Previous Clinical Trials

90 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Arm II (bladder emptying, CT, radiation) method been given regulatory authorization by the FDA?

"Our experts at Power assigned a rating of 2 to Arm II (bladder emptying, CT, radiation) due to the lack clinical evidence confirming efficacy but some studies indicating safety."

Answered by AI

Are there any vacancies for this research endeavor?

"As per the clinicaltrials.gov website, this research is currently not recruiting new participants; it was first posted on September 19th 2023 and most recently edited a week later. Nevertheless, there are over 1,350 other trials that are actively seeking volunteers at present."

Answered by AI

How many locations are providing access to this research study?

"This trial is accepting patients from Mayo Clinic in Jacksonville, Florida; Mayo Clinic Health System in Albert Lea, Minnesota; and Mayo Clinic Health Systems-Mankato in Mankato, Wisconsin. There are seven other sites offering this study as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Bradley (Brad) Stish 2023. "Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06037863.

All > Prostate Cancer Glendale