NCT04262609

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jul 2019Dec 2026

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

6.6 years

First QC Date

February 5, 2020

Last Update Submit

March 18, 2026

Conditions

Faecal IncontinenceProstate Cancer

Keywords

hypofractionated radiotherapyquality of lifecancer survivors

Outcome Measures

Primary Outcomes (5)

  • faecal incontinence after prostate radiation therapy

    grade of faecal incontinence in prostate cancer patients

    before radiotherapy (basal)

  • faecal incontinence after prostate radiation therapy

    grade of faecal incontinence in prostate cancer survivors

    change 2 years after completion of radiotherapy

  • faecal incontinence after prostate radiation therapy

    grade of faecal incontinence in prostate cancer survivors

    change 3 years after completion of radiotherapy

  • faecal incontinence after prostate radiation therapy

    grade of faecal incontinence in prostate cancer survivors

    change 4 years after completion of radiotherapy

  • faecal incontinence after prostate radiation therapy

    grade of faecal incontinence in prostate cancer survivors

    change 5 years after completion of radiotherapy

Secondary Outcomes (2)

  • Quality of life after prostate radiation therapy

    3 years after completion of radiotherapy

  • Quality of life after prostate radiation therapy

    5 years after completion of radiotherapy

Interventions

hypofractionated radiotherapyRADIATION

volumetric modulated moderately fractionated arc therapy

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Prostate cancer survivors treated in our department by hypofractionated radiotherapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Catalonia, 08227, Spain

Location

Related Publications (1)

  • 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.

    PMID: 40261490DERIVED

MeSH Terms

Conditions

EncopresisProstatic Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental DisordersGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Joan Lozano, MD

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 10, 2020

Study Start

July 1, 2019

Primary Completion

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)