Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

Active, not recruiting

• Conditions: Faecal Incontinence; Prostate Cancer

• Registration Number: NCT04262609
• Lead Sponsor: Consorci Sanitari de Terrassa

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

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Primary Completion: 2023-09-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
faecal incontinence after prostate radiation therapy	change 5 years after completion of radiotherapy	grade of faecal incontinence in prostate cancer survivors

Secondary Outcome Measures

Name	Time	Method
Quality of life after prostate radiation therapy	5 years after completion of radiotherapy	Quality of life in prostate cancer survivors comparing continents patients and incontinents patients

Trial Locations

Locations (1)

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Catalonia, Spain