Clinical trial NCT02597725: Salvage Radiotherapy After Radical Prostatectomy
Official title: Changes in Bladder Function After Surgery and Radiation Therapy for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Urodynamics
Late effects
Urinary Incontinence
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 70
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients in this cohort had surgery for prostate cancer in the period from 1999-2009. Because of a locale disease relapse the patients were treated with Salvage radiation therapy in the period from 2006-2010.

Brief summary: The purpose of this study is to describe the urinary morbidity as a result surgery and radiation therapy, in patients treated for prostate cancer.

All the patients will undergo a Urodynamic examination to verify the grade of Urinary morbidity.

Detailed description: Introduction:

There is a little knowledge on long-term urinary morbidity in patients treated with radical prostatectomy (RP) and salvage radiotherapy (SRT). Both treatments are potentially curative for localized prostate cancer (PC). Improved long-term survival makes the awareness of late effects from radiotherapy important.

Purpose:

The purpose of this study was to access, late urinary morbidity in patients treated with SRT. The patients included in this study will have an urodynamic examination. The results from the urodynamic examination will help us with a better understanding of the different symptoms and their grade, after treatment with RP and SRT because of PC.

Materials and methods:

A total of 67 patients will be invited to participate in this urodynamic study. The patients will undergo a urodynamic examination, included biomechanical examination of urethra. The examination is a standard procedure at the department of Urology, Aarhus University hospital, Denmark.

The patients will, in relation to the urodynamics, have taken two blood samples. The blood samples, will later on, be used to detect some of the genetic reasons for morbidity after radiotherapy.

Endpoint:

The primary endpoint is the outcome of different parameters as a result of the urodynamic examination.

Perspective:

The perspective of this study is to help understanding the efficacy og morbidity of salvage radiotherapy. The investigators hope to get a better understanding of the mechanisms related to urinary morbidity.

Eligibility criteria: Inclusion Criteria:

* Patients treated with salvage radiotherapy at Aarhus University hospital in the period from 2006-2010.

Exclusion Criteria:

* Other cancer types
* Severe comorbidity

Primary outcomes:
measure: Spontaneous urinary flow
timeFrame: 2 minutes
measure: Biomechanical properties of urethra
timeFrame: 10 minutes
measure: Cystometri
timeFrame: 20 minutes
measure: Uretal pressure profile
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Aarhus
name: Michael Borre, Professor
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Morten Høyer, Professor
role: STUDY_CHAIR
References: