Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

March 18, 2026 updated by: Joan Lozano Galan, Consorci Sanitari de Terrassa

Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Terrassa, Catalonia, Spain, 08227
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Prostate cancer survivors treated in our department by volumetric modulated hypofractionated arc therapy.

Description

Inclusion Criteria:

  • Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
faecal incontinence after prostate radiation therapy
Time Frame: before radiotherapy (basal)
grade of faecal incontinence in prostate cancer patients
before radiotherapy (basal)
faecal incontinence after prostate radiation therapy
Time Frame: change 2 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
change 2 years after completion of radiotherapy
faecal incontinence after prostate radiation therapy
Time Frame: change 3 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
change 3 years after completion of radiotherapy
faecal incontinence after prostate radiation therapy
Time Frame: change 4 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
change 4 years after completion of radiotherapy
faecal incontinence after prostate radiation therapy
Time Frame: change 5 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
change 5 years after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life after prostate radiation therapy
Time Frame: 3 years after completion of radiotherapy
Quality of life in prostate cancer survivors comparing continents patients and incontinents patients
3 years after completion of radiotherapy
Quality of life after prostate radiation therapy
Time Frame: 5 years after completion of radiotherapy
Quality of life in prostate cancer survivors comparing continents patients and incontinents patients
5 years after completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Joan Lozano, MD, Consorci Sanitari de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCORTCST2020-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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