Salvage Radiotherapy After Radical Prostatectomy

• Conditions: Prostate Cancer

• Registration Number: NCT02597725
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Status Verified: 2015-10
• Study First Submitted: 2015-10-07
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-04
• Last Update Submitted: 2015-11-04
• Study First Posted: 2015-11-05
• Last Update Posted: 2015-11-05
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

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

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Exclusion Criteria

• Other cancer types
• Severe comorbidity

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spontaneous urinary flow	2 minutes	The patients load the water at a special flow toilet
Biomechanical properties of urethra	10 minutes	Evaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.
Cystometri	20 minutes	The bladder is filled with saline with a flow rate of 60 mL/minute.
Uretal pressure profile	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.