A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial
Bibliographic record
Abstract
BACKGROUND: Many patients with nonmetastatic prostate cancer receive radiotherapy, which may be associated with acute cystitis, particularly if the volume of the urinary bladder is small. Three studies showed bladder volumes <200 ml or <180 ml to be associated with increased urinary toxicity. Therefore, it is important to maintain bladder volumes greater than 200 ml during as many radiation fractions as possible. Several studies investigated drinking protocols, where patients were asked to drink a certain amount of water prior to radiotherapy sessions. This may require considerable discipline from the patients, who are predominantly older adults. Adherence to a drinking protocol may be facilitated by a mobile app that reminds patients to drink water prior to each radiation session. This study investigates the effect of such an app on bladder filling status in patients with prostate cancer undergoing external beam radiotherapy (EBRT) alone. OBJECTIVE: The primary goal of this study is to evaluate the impact of an app that reminds patients irradiated for prostate cancer to drink 300 ml of water prior to each radiotherapy session on the number of fractions with bladder volumes <200 ml during the radiotherapy course. METHODS: This ongoing phase 2 aims to recruit 28 patients treated with EBRT alone for nonmetastatic prostate cancer. Radiotherapy will be administered using normo-fractionation, with doses ranging from 70 to 80 Gy in 35 to 40 fractions of 2 Gy, preferably with volumetric-modulated arc therapy (VMAT). Treatment volumes include the prostate with or without the seminal vesicles. RESULTS: Recruitment for this trial will start in March 2025 and is planned to be completed in October 2026. The study is scheduled to conclude in December 2026. CONCLUSIONS: This trial is the first to evaluate the impact of a reminder app on the number of radiotherapy fractions with bladder volumes <200 ml in patients undergoing irradiation for localized prostate cancer. TRIAL REGISTRATION: Clinicaltrials.gov NCT06653751; https://clinicaltrials.gov/show/NCT06653751. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/68179.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.025 | 0.028 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.006 | 0.005 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.008 |
| Insufficient payload (model declined to judge) | 0.059 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".