Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

• Sponsor: Consorci Sanitari de Terrassa (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04262609
• Collaborator: (none)
• Enrollment: 200
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Faecal Incontinence; Prostate Cancer	Radiation: hypofractionated radiotherapy

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

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Outcome Measures

Primary Outcome Measures

1. faecal incontinence after prostate radiation therapy [before radiotherapy (basal)]

   grade of faecal incontinence in prostate cancer patients

2. faecal incontinence after prostate radiation therapy [change 2 years after completion of radiotherapy]

   grade of faecal incontinence in prostate cancer survivors

3. faecal incontinence after prostate radiation therapy [change 3 years after completion of radiotherapy]

   grade of faecal incontinence in prostate cancer survivors

4. faecal incontinence after prostate radiation therapy [change 4 years after completion of radiotherapy]

   grade of faecal incontinence in prostate cancer survivors

5. faecal incontinence after prostate radiation therapy [change 5 years after completion of radiotherapy]

   grade of faecal incontinence in prostate cancer survivors

Secondary Outcome Measures

1. Quality of life after prostate radiation therapy [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 [5 years after completion of radiotherapy]

   Quality of life in prostate cancer survivors comparing continents patients and incontinents patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male

Inclusion Criteria:

• Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion Criteria:

• Relapse of prostate cancer

• Other active cancer

• Mental disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Consorci Sanitari de Terrassa	Terrassa	Catalonia	Spain	08227

Sponsors and Collaborators

• Consorci Sanitari de Terrassa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joan Lozano Galan, Principal investigator, Consorci Sanitari de Terrassa
• ClinicalTrials.gov Identifier: NCT04262609
• Other Study ID Numbers: ONCORTCST2020-1
• First Posted: Feb 10, 2020
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joan Lozano Galan, Principal investigator, Consorci Sanitari de Terrassa: hypofractionated radiotherapy; quality of life; cancer survivors
• Additional relevant MeSH terms: Prostatic Neoplasms; Fecal Incontinence

Study Results

No Results Posted as of Mar 9, 2022