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

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed
    • Primary completion date changed from estimate of Dec 30, 2027 to Feb 23, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Minor Re-verified, no change to tracked fieldsv8
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Sep 19, 2028 to Dec 30, 2027
    • Site details revised at 7 of 7 sites
    v7
  4. Minor Enrollment target: 154 to 168
    • Interventions: Best Practice (Other), Computed Tomography (Procedure), Electronic Health Record Review (Other), Imaging Technique (Procedure)… to Best Practice (Other), Computed Tomography (Procedure), Electronic Health Record Review (Other), Imaging Procedure (Procedure)…
    • Site contacts updated at 7 of 7 sites
    v6
  5. Minor Study description revisedv5
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  1. Minor Site details revised at 1 of 7 sitesv4
  2. Notable Phase: Phase 2 to Not applicablev3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 7 of 7 sites
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06037863
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)
Prostate Carcinoma
Related terms Prostatic Neoplasms
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov