HRQOL in Prostate Cancer Patients Treated With Radiotherapy
PRORAD
Health-Related Quality of Life in Prostate Cancer Patients Treated With Radiotherapy
2 other identifiers
observational
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
1 active site
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 Start
First participant enrolled
April 8, 2019
CompletedFirst Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
August 19, 2025
August 1, 2025
8.2 years
November 28, 2022
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
EPIC questionnaire score on urinary domain
Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
Year 1 - Year 4
EPIC questionnaire score on bowel domain
Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
Year 1 - Year 4
Sexual functioning score on IIEF-5 questionnaire
Sexual functioning score on International Index of Erectile Function (IIEF-5) questionnaire: 1 to 25 scale, higher scores imply better function
Year 1- Year 4
Secondary Outcomes (7)
Acute rectal bleeding, on symptom checklist (patient-reported)
During radiotherapy - 3 months after radiotherapy
Acute mucous discharge, on symptom checklist (patient-reported)
During radiotherapy - 3 months after radiotherapy
Late moderate to severe urinary incontinence
Year 1 - Year 4
Late moderate to severe urinary frequency during the night
Year 1 - Year 4
Late moderate to severe incontinence for stools
Year 1 - Year 4
- +2 more secondary outcomes
Other Outcomes (4)
General health score on EQ-5D-5L questionnaire
Year 1- Year 4
Acute moderate to severe rectal discomfort
During radiotherapy - 3 months after radiotherapy
Late watery bowel movements
Year 1 - Year 4
- +1 more other outcomes
Study Arms (6)
Applied radiotherapy protocol (subcohort) 1
60 Gy in 20 fractions of 3 Gy external beam radiotherapy
Applied radiotherapy protocol (subcohort) 2
42.7 Gy in 7 fractions of 6.1 Gy external beam radiotherapy
Applied radiotherapy protocol (subcohort) 3
38 Gy in 4 fractions of 9 Gy stereotactic external beam radiotherapy
Applied radiotherapy protocol (subcohort) 4
27 Gy in 2 fractions of 13.5 Gy brachytherapy
Applied radiotherapy protocol (subcohort) 5
72 Gy in 36 fractions of 2 Gy postoperative external beam radiotherapy
Applied radiotherapy protocol (subcohort) 6
70 Gy in 35 fractions of 2 Gy on prostate combined with 52 Gy in 28 fractions of 2 Gy on pelvic lymph node areas, external beam radiotherapy.
Interventions
Radiotherapy is delivered with linear accelerators or cyberknife (external beam radiotherapy), or local irradiation with high dose rate brachytherapy (brachytherapy)
Eligibility Criteria
Clinically T1c-T4, N0 (or N+ in case of EBRT-LN+), M0 prostate cancer patients referred for radiotherapy to the Erasmus Medical Center.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Dutch Cancer Societycollaborator
Study Sites (1)
Radiotherapy, Erasmus MC Cancer Center
Rotterdam, South Holland, 3015 GD, Netherlands
Related Publications (2)
Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.
PMID: 11113727BACKGROUNDUtomo E, Blok BF, Pastoor H, Bangma CH, Korfage IJ. The measurement properties of the five-item International Index of Erectile Function (IIEF-5): a Dutch validation study. Andrology. 2015 Nov;3(6):1154-9. doi: 10.1111/andr.12112. Epub 2015 Oct 9.
PMID: 26453539BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Incrocci, MD PhD
Erasmus Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Epidemiologist, Project Leader, PhD
Study Record Dates
First Submitted
November 28, 2022
First Posted
December 9, 2022
Study Start
April 8, 2019
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2030
Last Updated
August 19, 2025
Record last verified: 2025-08