NCT06784115

Brief Summary

The primary goal of this study is to assess the impact of an app that reminds patients treated with hypofractionated radiotherapy (HF-RT) for prostate cancer to drink water prior to each radiotherapy session on the number of bladder volumes \<200 ml during the HF-RT course and to demonstrate that this number is lower than without using an app (historical control group).

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Feb 2025Jan 2027

First Submitted

Initial submission to the registry

January 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

January 13, 2025

Last Update Submit

January 17, 2025

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Keywords

prostate cancerradiotherapyhypofractionationmobile applicationbladder filling

Outcome Measures

Primary Outcomes (1)

  • Number of fractions with bladder volumes <200 ml at the end of the radiotherapy course

    The primary endpoint is the number of radiation fractions with bladder volumes \<200 ml at the end of the radiotherapy course. The bladder volume at each radiation fraction is calculated from the corresponding Cone-Beam Computed Tomography (CBCT).

    through study completion, an average of 4 weeks

Secondary Outcomes (2)

  • Rate of patient satisfaction with the reminder app

    through study completion, an average of 4 weeks

  • Degree of the impact of the reminder app

    through study completion, an average of 4 weeks

Study Arms (1)

Support by a reminder app

EXPERIMENTAL

Patients are supported by a Reminder App. The purpose of the app is to remind patients irradiated for prostate cancer in an intuitive, unobtrusive and supportive way to drink 300 ml of water 45 minutes prior to each radiation session. This is supposed to have an impact on the number of bladder volumes \<200 ml. Bladder volumes \<200 ml were previously shown to be associated with increased urinary toxicity.

Device: Reminder App

Interventions

Reminder AppDEVICE

The purpose of the app is to remind patients irradiated for prostate cancer in an intuitive, unobtrusive and supportive way to drink 300 ml of water 45 minutes prior to each radiation session.

Support by a reminder app

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven prostate cancer
  • Indication for definitive HF-RT
  • Possession of and ability to use a smartphone
  • Bladder volume at CT-simulation \<200 ml
  • Male gender
  • Age ≥18 years
  • Written informed consent
  • Capacity of the patient to contract

You may not qualify if:

  • Radiotherapy of pelvic lymph nodes
  • Expected non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark

Vejle, Southern Denmark, 7100, Denmark

Location

Medical Practice for Radiotherapy and Radiation Oncology

Hanover, Lower Saxony, 30161, Germany

Location

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Radiation Oncology Department, Hospital Universitario Cruces/Biobizkaia Health Research Institute University of the Basque Country

Barakaldo, Basque Country, 48903, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Dirk Rades, Prof. Dr.

    Department of Radiation Oncology, University of Lubeck, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, Prof. Dr.

CONTACT

0049-451-500dirk.rades@uksh.de

Florian Cremers, Dr. rer. nat.

CONTACT

0049-451-500florian.cremers@uksh.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 20, 2025

Study Start

February 15, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)ES(1)DE(2)