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Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04262609
Enrollment
200
Registered
2020-02-10
Start date
2019-07-01
Completion date
2026-12-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Faecal Incontinence, Prostate Cancer

Keywords

hypofractionated radiotherapy, quality of life, cancer survivors

Brief summary

The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

Detailed description

The investigators know that high doses of irradiation in the anal sphincter are associated with more chronic fecal leaks in survivors irradiated by normofractionated radiotherapy prostate cancer. The safe dose of irradiation of the anal sphincter with radiotherapy modern techniques (volumetric modulated arc therapy with moderately hypofracctionation) is unknown. Urgency and faecal incontinence greatly affects the quality of life of these patients. Therefore, it is interesting to implement strategies to protect the anatomical structures involved in fecal continence. The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with modern moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence. The investigators also want to evaluate the quality of life of these patients

Interventions

RADIATIONhypofractionated radiotherapy

volumetric modulated moderately fractionated arc therapy

Sponsors

Consorci Sanitari de Terrassa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

Inclusion criteria

* Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion criteria

* Relapse of prostate cancer * Other active cancer * Mental disorder

Design outcomes

Primary

MeasureTime frameDescription
faecal incontinence after prostate radiation therapybefore radiotherapy (basal)grade of faecal incontinence in prostate cancer patients

Secondary

MeasureTime frameDescription
Quality of life after prostate radiation therapy3 years after completion of radiotherapyQuality of life in prostate cancer survivors comparing continents patients and incontinents patients

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORJoan Lozano, MD

Consorci Sanitari de Terrassa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026