Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial (NCT06037863)
RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic in Arizona — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
- Best Practice (OTHER)
- Computed Tomography (PROCEDURE)
- Electronic Health Record Review (OTHER)
- Imaging Procedure (PROCEDURE)
- Questionnaire Administration (OTHER)
- Radiation Therapy (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Mayo Clinic in Arizona — Scottsdale, Arizona
- Mayo Clinic in Florida — Jacksonville, Florida
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota
- Mayo Clinic Health Systems-Mankato — Mankato, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota
- Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin
- Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prostate Carcinoma
- Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer — Phoenix, Arizona
- To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring — Fairbanks, Alaska
- Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization — Tampa, Florida
- Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC) — Philadelphia, Pennsylvania
- Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer — Rochester, Minnesota
Explore by condition: All Prostate Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.