Prostate CancerSRTNCT02597725
Salvage Radiotherapy After Radical Prostatectomy
An observational study of Prostate Cancer, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients treated with salvage radiotherapy at Aarhus University hospital in the period from 2006-2010.
Who cannot join
- Other cancer types
- Severe comorbidity
Trial locations and contacts
No sites are listed yet.
Helene Nørrelund contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Urodynamics, Late effects, Urinary Incontinence
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urodynamics | There is no intervention in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous urinary flow
The patients load the water at a special flow toilet
Measured: 2 minutes
Biomechanical properties of urethra
Evaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.
Measured: 10 minutes
Cystometri
The bladder is filled with saline with a flow rate of 60 mL/minute.
Measured: 20 minutes
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Borre, Professor, Study chair, University of AarhusMorten Høyer, Professor, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597725
- Sponsor's protocol ID
- Urodynamics in prostate cancer
- Acronym
- SRT
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bladder Function After Surgery and Radiation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02597725
- Acronym / sponsor ID
- SRT / Urodynamics in prostate cancer
- Conditions
- Prostate Cancer
- Keywords
- Urodynamics, Late effects, Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urodynamics | – | –There is no intervention in this study. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients treated with salvage radiotherapy at Aarhus University hospital in the period from 2006-2010.
Key exclusion criteria (2 listed)
- Other cancer types
- Severe comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spontaneous urinary flow
Time frame: 2 minutes
The patients load the water at a special flow toilet
Biomechanical properties of urethra
Time frame: 10 minutes
Evaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.
Cystometri
Time frame: 20 minutes
The bladder is filled with saline with a flow rate of 60 mL/minute.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Nørrelund contact
Michael Borre, Professor study chair
University of Aarhus
Morten Høyer, Professor study chair
University of Aarhus
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Ervandian, MD (004523392309, mservandian@ki.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous urinary flow (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.