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NCT Number: NCT04262609

Faecal Incontinence in Prostate Cancer Survivors Treated Whith 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Faecal Incontinence Behavior Behavioral Symptoms Elimination Disorders Encopresis Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Consorci Sanitari de Terrassa

Terrassa, Catalonia, 08227, Spain

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion criteria

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

Treatment and study plan

Hypofractionated radiotherapy

Radiation

volumetric modulated moderately fractionated arc therapy

Primary outcomes

  1. faecal incontinence after prostate radiation therapy

    Time frame: before radiotherapy (basal)

    grade of faecal incontinence in prostate cancer patients

  2. faecal incontinence after prostate radiation therapy

    Time frame: change 2 years after completion of radiotherapy

    grade of faecal incontinence in prostate cancer survivors

  3. faecal incontinence after prostate radiation therapy

    Time frame: change 3 years after completion of radiotherapy

    grade of faecal incontinence in prostate cancer survivors

  4. faecal incontinence after prostate radiation therapy

    Time frame: change 4 years after completion of radiotherapy

    grade of faecal incontinence in prostate cancer survivors

  5. faecal incontinence after prostate radiation therapy

    Time frame: change 5 years after completion of radiotherapy

    grade of faecal incontinence in prostate cancer survivors

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2020
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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