Salvage Radiotherapy After Radical Prostatectomy

Prostate Cancer Clinical Trial

— SRT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02597725
• Other study ID #: Urodynamics in prostate cancer
• Status: Not yet recruiting
• Phase: N/A
• First received: October 7, 2015
• Last updated: November 4, 2015
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2015
• Source: University of Aarhus
• Contact: Maria Ervandian, MD
• Phone: 004523392309
• Email: mservandian[@]ki.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous urinary flow	The patients load the water at a special flow toilet	2 minutes	No
Primary	Biomechanical properties of urethra	Evaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.	10 minutes	No
Primary	Cystometri	The bladder is filled with saline with a flow rate of 60 mL/minute.	20 minutes	No
Primary	Uretal pressure profile	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	No