Clinical trial · Observational
HRQOL in Prostate Cancer Patients Treated With Radiotherapy
Health-Related Quality of Life in Prostate Cancer Patients Treated With Radiotherapy
NCT05645237CI-TRIAL-00093823PRORADactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Applied radiotherapy protocol (subcohort) 1
- description
- 60 Gy in 20 fractions of 3 Gy external beam radiotherapy
- interventionNames
- Radiation: radiotherapy
- label
- Applied radiotherapy protocol (subcohort) 2
- description
- 42.7 Gy in 7 fractions of 6.1 Gy external beam radiotherapy
- interventionNames
- Radiation: radiotherapy
- label
- Applied radiotherapy protocol (subcohort) 3
- description
- 38 Gy in 4 fractions of 9 Gy stereotactic external beam radiotherapy
- interventionNames
- Radiation: radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDWei 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 11113727
- BACKGROUNDUtomo 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 26453539