Salvage Radiotherapy After Radical Prostatectomy (SRT)

November 4, 2015 updated by: University of Aarhus

Changes in Bladder Function After Surgery and Radiation Therapy for Prostate Cancer

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Other cancer types
  • Severe comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Urodynamics
There is no intervention in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous urinary flow
Time Frame: 2 minutes
The patients load the water at a special flow toilet
2 minutes
Biomechanical properties of urethra
Time Frame: 10 minutes
Evaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.
10 minutes
Cystometri
Time Frame: 20 minutes
The bladder is filled with saline with a flow rate of 60 mL/minute.
20 minutes
Uretal pressure profile
Time Frame: 10 minutes
To evaluate the uretal pressure profile. The water pump perfused saline at a flow rate of 1 mL, while the catheter. attached to an automatic pulling device, was pulled out of the urethra at 2 mm/s.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Michael Borre, Professor, University of Aarhus
  • Study Chair: Morten Høyer, Professor, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urodynamics in prostate cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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