Clinical trial NCT04262609: Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy
Official title: Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Faecal Incontinence
Prostate Cancer
Keywords: hypofractionated radiotherapy
quality of life
cancer survivors
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer survivors treated in our department by volumetric modulated hypofractionated arc therapy.

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.

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

Eligibility criteria: Inclusion Criteria:

* Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion Criteria:

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

Primary outcomes:
measure: faecal incontinence after prostate radiation therapy
timeFrame: before radiotherapy (basal)
measure: faecal incontinence after prostate radiation therapy
timeFrame: change 2 years after completion of radiotherapy
measure: faecal incontinence after prostate radiation therapy
timeFrame: change 3 years after completion of radiotherapy
measure: faecal incontinence after prostate radiation therapy
timeFrame: change 4 years after completion of radiotherapy
measure: faecal incontinence after prostate radiation therapy
timeFrame: change 5 years after completion of radiotherapy
Secondary outcomes:
measure: Quality of life after prostate radiation therapy
timeFrame: 3 years after completion of radiotherapy
measure: Quality of life after prostate radiation therapy
timeFrame: 5 years after completion of radiotherapy
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Catalonia
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Joan Lozano, MD
role: PRINCIPAL_INVESTIGATOR
References: