Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

Prostate Cancer Clinical Trial

Official title:

Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04262609
• Other study ID #: ONCORTCST2020-1
• Status: Active, not recruiting
• Start date: July 1, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: September 8, 2023
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion Criteria:

• Relapse of prostate cancer

• Other active cancer

• Mental disorder

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• hypofractionated radiotherapy
volumetric modulated moderately fractionated arc therapy

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	faecal incontinence after prostate radiation therapy	grade of faecal incontinence in prostate cancer patients	before radiotherapy (basal)
Primary	faecal incontinence after prostate radiation therapy	grade of faecal incontinence in prostate cancer survivors	change 2 years after completion of radiotherapy
Primary	faecal incontinence after prostate radiation therapy	grade of faecal incontinence in prostate cancer survivors	change 3 years after completion of radiotherapy
Primary	faecal incontinence after prostate radiation therapy	grade of faecal incontinence in prostate cancer survivors	change 4 years after completion of radiotherapy
Primary	faecal incontinence after prostate radiation therapy	grade of faecal incontinence in prostate cancer survivors	change 5 years after completion of radiotherapy
Secondary	Quality of life after prostate radiation therapy	Quality of life in prostate cancer survivors comparing continents patients and incontinents patients	3 years after completion of radiotherapy
Secondary	Quality of life after prostate radiation therapy	Quality of life in prostate cancer survivors comparing continents patients and incontinents patients	5 years after completion of radiotherapy