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Salvage Radiotherapy After Radical Prostatectomy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02597725
Acronym
SRT
Enrollment
70
Registered
2015-11-05
Start date
2015-11-30
Completion date
2016-07-31
Last updated
2015-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Urodynamics, Late effects, Urinary Incontinence

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.

Interventions

None listed

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Other cancer types * Severe comorbidity

Design outcomes

Primary

MeasureTime frameDescription
Spontaneous urinary flow2 minutesThe patients load the water at a special flow toilet
Biomechanical properties of urethra10 minutesEvaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.
Cystometri20 minutesThe bladder is filled with saline with a flow rate of 60 mL/minute.
Uretal pressure profile10 minutesTo 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.

Contacts

Primary ContactMaria Ervandian, MD
mservandian@ki.au.dk004523392309
Backup ContactHelene Nørrelund
hwn@clin.au.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026