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Clinical Trials in the Netherlands / NCT05645237
Active, not recruiting Observational

HRQOL in Prostate Cancer Patients Treated With Radiotherapy

NCT05645237 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Observational
Started
2019-04-08
Last updated
2025-08-19

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

radiotherapy

radiotherapy: Radiotherapy is delivered with linear accelerators or cyberknife (external beam radiotherapy), or local irradiation with high dose rate brachytherapy (brachytherapy)

Study summary

The study primarily aims at evaluating health-related quality of life after radiotherapy for prostate cancer, using modern hypofractionated radiotherapy schedules. Study design is a prospective observational cohort study. All patients give written informed consent and fill out online validated questionnaires before, during, and after radiotherapy (yearly) up to 5 years post-treatment.

Eligibility

Sex
MALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Clinically T1c-T4, N0 (or N+ in case of EBRT-LN+), M0 prostate cancer patient referred for radiotherapy. * Willing and capable to fill out Dutch questionnaires on health-related items at a computer (online questionnaires). * Signed written Informed Consent. Exclusion Criteria: * Previously radiation treatment in the pelvic region, for any reason. * Diagnosed with other tumor in the past 12 months or known with tumor progression of another tumor. * Postoperative radiotherapy with dose levels \< 72 Gy.

Primary outcome measure(s)

  • EPIC questionnaire score on urinary domain — Year 1 - Year 4
    Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
  • EPIC questionnaire score on bowel domain — Year 1 - Year 4
    Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
  • Sexual functioning score on IIEF-5 questionnaire — Year 1- Year 4
    Sexual functioning score on International Index of Erectile Function (IIEF-5) questionnaire: 1 to 25 scale, higher scores imply better function

Trial sites (1)

FacilityCityRegionStatus
Radiotherapy, Erasmus MC Cancer Center Rotterdam South Holland

More Erasmus Medical Center trials in the Netherlands

HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT Starting soon
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Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial Recruiting

Other trials for the same condition

Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer Recruiting
Detection of Minimal Residual Disease Post-prostatectomy Recruiting
Standard Moderately Hypofractionated RT vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer Active, not recruiting
EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT) Recruiting
The 4D PICTURE Project: Evaluating Metro Mapping As a Method to Support Shared Decision Making in Oncology Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05645237 on ClinicalTrials.gov ↗ ← All trials in the Netherlands