Faecal IncontinenceNCT04262609
Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy
An observational study of Faecal Incontinence and Prostate Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Faecal Incontinence, Prostate Cancer
- What is being tested?
- hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: Prostate cancer survivors treated in our department by volumetric modulated hypofractionated arc therapy.
Who may be able to join
- Prostate cancer survivors treated in our department by hypofractionated radiotherapy
Who cannot join
- Relapse of prostate cancer
- Other active cancer
- Mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Faecal Incontinence, Prostate Cancer
- Being tested
- hypofractionated radiotherapy
- Keywords
- hypofractionated radiotherapy, quality of life, cancer survivors
- Medical subject headings
- Encopresis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiotherapyRadiation
volumetric modulated moderately fractionated arc therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
faecal incontinence after prostate radiation therapy
grade of faecal incontinence in prostate cancer patients
Measured: before radiotherapy (basal)
faecal incontinence after prostate radiation therapy
grade of faecal incontinence in prostate cancer survivors
Measured: change 2 years after completion of radiotherapy
faecal incontinence after prostate radiation therapy
grade of faecal incontinence in prostate cancer survivors
Measured: change 3 years after completion of radiotherapy
faecal incontinence after prostate radiation therapy
grade of faecal incontinence in prostate cancer survivors
Measured: change 4 years after completion of radiotherapy
faecal incontinence after prostate radiation therapy
grade of faecal incontinence in prostate cancer survivors
Measured: change 5 years after completion of radiotherapy
Secondary outcomes (2)
Quality of life after prostate radiation therapy
Quality of life in prostate cancer survivors comparing continents patients and incontinents patients
Measured: 3 years after completion of radiotherapy
Quality of life after prostate radiation therapy
Quality of life in prostate cancer survivors comparing continents patients and incontinents patients
Measured: 5 years after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Jul 2019
- Primary completion1 Feb 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Lozano Galan, Consorci Sanitari de Terrassa
- Investigators
- Joan Lozano, MD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262609
- Sponsor's protocol ID
- ONCORTCST2020-1
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2020
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lozano J, Feltes N, Colomer M, Lizondo M, Carmona M, Romero C, Ribas Y, Paredes S, Galdeano M, Sole JM. Fecal incontinence after moderately hypofractionated volumetric modulated arc therapy for prostate cancer: incidence and impact on quality of life. Clin Transl Oncol. 2025 Oct;27(10):4003-4010. doi: 10.1007/s12094-025-03926-w. Epub 2025 Apr 22.
PubMed 40261490
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy
- ClinicalTrials.gov ID
- NCT04262609
- Acronym / sponsor ID
- ONCORTCST2020-1
- Conditions
- Faecal Incontinence, Prostate Cancer
- Keywords
- hypofractionated radiotherapy, quality of life, cancer survivors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer survivors treated in our department by volumetric modulated hypofractionated arc therapy.
Key inclusion criteria (1 listed)
- Prostate cancer survivors treated in our department by hypofractionated radiotherapy
Key exclusion criteria (3 listed)
- Relapse of prostate cancer
- Other active cancer
- Mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypofractionated radiotherapyvolumetric modulated moderately fractionated arc therapy | Radiation | – |
Primary outcome
faecal incontinence after prostate radiation therapy
Time frame: before radiotherapy (basal)
grade of faecal incontinence in prostate cancer patients
faecal incontinence after prostate radiation therapy
Time frame: change 2 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
faecal incontinence after prostate radiation therapy
Time frame: change 3 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
faecal incontinence after prostate radiation therapy
Time frame: change 4 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
faecal incontinence after prostate radiation therapy
Time frame: change 5 years after completion of radiotherapy
grade of faecal incontinence in prostate cancer survivors
2 secondary outcomes
Quality of life after prostate radiation therapy
Time frame: 3 years after completion of radiotherapy
Quality of life after prostate radiation therapy
Time frame: 5 years after completion of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 40261490Lozano J, Feltes N, Colomer M, Lizondo M, Carmona M, Romero C, Ribas Y, Paredes S, Galdeano M, Sole JM. Fecal incontinence after moderately hypofractionated volumetric modulated arc therapy for prostate cancer: incidence and impact on quality of life. Clin Transl Oncol. 2025 Oct;27(10):4003-4010. doi: 10.1007/s12094-025-03926-w. Epub 2025 Apr 22.
- Individual participant dataSharing planned: No
Related trials for Faecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Lozano, MD principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Faecal Incontinence and Prostate Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
faecal incontinence after prostate radiation therapy (time frame: before radiotherapy (basal)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.