Impact of bladder fullness on prostate cancer radiation therapy

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

This study tests whether having a full or empty bladder before radiation therapy affects urinary symptoms in men with prostate cancer three months after treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Mayo Clinic (other)
• Drugs / interventions: radiation
• Locations: 7 sites (Scottsdale, Arizona and 6 other locations)
• Trial ID: NCT06037863 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of having an empty bladder versus a full bladder before undergoing a CT simulation for radiation therapy in patients with prostate cancer. The primary objective is to determine if an empty bladder is non-inferior to a full bladder in terms of urinary symptoms reported by patients three months after treatment. Secondary objectives include assessing bowel symptoms and comparing physician-assessed toxicity between the two groups. The study also explores dosimetric parameters and patient experiences related to bladder status during treatment.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with histologically confirmed prostate cancer who are scheduled for definitive radiation therapy.

Not a fit: Patients who are planned for brachytherapy or have significant urinary incontinence may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved patient comfort and reduced urinary symptoms during radiation therapy for prostate cancer.

How similar studies have performed: Other studies have explored bladder management during radiation therapy, but this specific comparison of bladder fullness has not been widely tested.

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

Where this trial is running

Scottsdale, Arizona and 6 other locations

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (RECRUITING)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (RECRUITING)
• Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (RECRUITING)
• Mayo Clinic Health Systems-Mankato — Mankato, Minnesota, United States (RECRUITING)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
• Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin, United States (RECRUITING)
• Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Bradley J. Stish, M.D. — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office

Conditions: Prostate Carcinoma