Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

NCT ID: NCT04262609

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

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Faecal Incontinence Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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hypofractionated radiotherapy

volumetric modulated moderately fractionated arc therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion Criteria

* Relapse of prostate cancer
* Other active cancer
* Mental disorder
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Joan Lozano Galan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Lozano, MD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de Terrassa

Locations

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Consorci Sanitari de Terrassa

Terrassa, Catalonia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 40261490 (View on PubMed)

Other Identifiers

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ONCORTCST2020-1

Identifier Type: -

Identifier Source: org_study_id

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