Prostate CancerNCT00901420
Urodynamic Evaluation in Post-radiation Salvage Prostatectomy Patients
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: The primary objective of this study is to determine whether bladder compliance is significantly lower in men who undergo prostatectomy for recurrence following primary radiation therapy than in men who undergo prostatectomy as primary treatment. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Urodynamics Test and Questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2010
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men, seen at MD Anderson Cancer Center, who underwent radical prostatectomy as the first-line treatment for their prostate cancer or underwent salvage prostatectomy for recurrence after first-line radiation treatment; or underwent prostatectomy at least one year prior to study entry date or received perioperative (or peri-XRT) chemotherapy or hormone therapy.
Who may be able to join
- Men who have undergone radical prostatectomy, via an open or minimally invasive approach, as primary treatment for a diagnosis of prostate cancer.
- Men who have undergone salvage prostatectomy for recurrence after first-line radiation therapy for prostate cancer.
- Men who underwent prostatectomy at least one year prior to study entry date. Men who received perioperative (or peri-XRT) chemotherapy or hormone therapy are eligible.
Who cannot join
- Men who underwent other primary or secondary treatments for prostate cancer--hormone therapy as only treatment, cryosurgery, adjuvant radiation after prostatectomy
- Men with a history of neurogenic bladder, as demonstrated by previous urodynamics.
- Men with a history of severe outlet obstruction due to longstanding benign prostatic hyperplasia. This will be demonstrated objectively by documentation in the patient's history of preoperative AUA symptom score greater than 15 or a history of urinary retention or nocturia greater than 2 episodes per night.
- Men who underwent additional reconstructive procedures at the time of or subsequent to prostatectomy, including augmentation, urethral sling, or urinary diversion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Urodynamic Evaluation in Post-Radiation Salvage Prostatectomy Versus Prostatectomy-only Patients
Objectives:
The primary objective of this study is to determine whether bladder compliance is significantly lower in men who undergo prostatectomy for recurrence following primary radiation therapy than in men who undergo prostatectomy as primary treatment.
The secondary objective is to examine the quality-of-life items addressed in the UCLA Prostate Cancer Index for differences between the two populations. The investigators will also look at secondary objective urodynamic measures, such as bladder capacity, to assess for a difference.
Read the detailed description
Study Participation:
You will come to the urology clinic for 1 visit. At this visit, a video urodynamics test will be performed. The urodynamics test is used to check bladder and urinary function using pressure and volume measurements with x-ray images.
Pressure-monitoring catheters will be inserted into your bladder and rectum, and your bladder function will be checked as the bladder is slowly filled with fluid. Measurements will then be made of your bladder capacity (the volume of urine the bladder can hold), bladder and abdominal (stomach) pressures, and bladder compliance (the bladder's ability to hold urine) throughout the course of this study. This procedure will take about 90 minutes to complete.
After the urodynamics test is completed, you will complete a questionnaire about your urinary function and your quality-of-life (regarding daily living after surgical treatment for prostate cancer). The questionnaire will take about 30 minutes to complete.
If you have had urodynamic testing with Dr. Westney within the past year, we would like your consent to use the data from that test, and also for completion of the questionnaire mentioned in the previous paragraph. You will complete this informed consent and questionnaire being sent with a return envelope and will not need to come to the urology clinic for a visit.
Length of Study:
Once you have completed the urodynamics testing and questionnaire, your participation on this study is complete.
This is an investigational study. The video urodynamics test is approved by the FDA and commercially available. Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Urodynamics Test, Questionnaire
- Keywords
- Prostate, Urodynamic Evaluation, Prostatectomy, Salvage prostatectomy, Bladder compliance, Radiation Therapy, External beam radiation therapy, Quality-of-life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamics TestProcedure or surgery
90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum.
QuestionnaireBehavioural
Survey of urinary function and quality-of-life (regarding daily living after surgical treatment for prostate cancer), taking 30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Prostatectomy | Not described Receives: Procedure: Urodynamics Test; Behavioral: Questionnaire | |
| Prostatectomy After Radiation Therapy | Not described Receives: Procedure: Urodynamics Test; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Urodynamic Changes Related to Radiation Post Salvage Prostatectomy versus Prostatectomy Only
Comparison of urodynamic changes related to radiation by performing urodynamics (measurement of bladder pressure, electrical activity, and radiographic imaging) in patients post salvage prostatectomy versus prostatectomy only, using a 2-sample t-test to test for differences between the 2 groups of men with respect to urodynamic score.
Measured: Compilation of patient urodynamics test completed in single 90 minute office visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Terminated due to slow accrual.
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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ouida L. Westney, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901420
- Sponsor's protocol ID
- 2006-0384
- Status last verified
- Jul 2012
- First submitted
- 12 May 2009
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Urodynamic Evaluation in Post-Radiation Salvage Prostatectomy Versus Prostatectomy-only Patients
- ClinicalTrials.gov ID
- NCT00901420
- Acronym / sponsor ID
- 2006-0384
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Urodynamic Evaluation, Prostatectomy, Salvage prostatectomy, Bladder compliance, Radiation Therapy, External beam radiation therapy, Quality-of-life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 May 2009 (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.
Objectives:
The primary objective of this study is to determine whether bladder compliance is significantly lower in men who undergo prostatectomy for recurrence following primary radiation therapy than in men who undergo prostatectomy as primary treatment.
The secondary objective is to examine the quality-of-life items addressed in the UCLA Prostate Cancer Index for differences between the two populations. The investigators will also look at secondary objective urodynamic measures, such as bladder capacity, to assess for a difference.
Detailed description
Study Participation:
You will come to the urology clinic for 1 visit. At this visit, a video urodynamics test will be performed. The urodynamics test is used to check bladder and urinary function using pressure and volume measurements with x-ray images.
Pressure-monitoring catheters will be inserted into your bladder and rectum, and your bladder function will be checked as the bladder is slowly filled with fluid. Measurements will then be made of your bladder capacity (the volume of urine the bladder can hold), bladder and abdominal (stomach) pressures, and bladder compliance (the bladder's ability to hold urine) throughout the course of this study. This procedure will take about 90 minutes to complete.
After the urodynamics test is completed, you will complete a questionnaire about your urinary function and your quality-of-life (regarding daily living after surgical treatment for prostate cancer). The questionnaire will take about 30 minutes to complete.
If you have had urodynamic testing with Dr. Westney within the past year, we would like your consent to use the data from that test, and also for completion of the questionnaire mentioned in the previous paragraph. You will complete this informed consent and questionnaire being sent with a return envelope and will not need to come to the urology clinic for a visit.
Length of Study:
Once you have completed the urodynamics testing and questionnaire, your participation on this study is complete.
This is an investigational study. The video urodynamics test is approved by the FDA and commercially available. Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostatectomy | – | Procedure: Urodynamics Test, Behavioral: Questionnaire |
| Prostatectomy After Radiation Therapy | – | Procedure: Urodynamics Test, Behavioral: Questionnaire |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men, seen at MD Anderson Cancer Center, who underwent radical prostatectomy as the first-line treatment for their prostate cancer or underwent salvage prostatectomy for recurrence after first-line radiation treatment; or underwent prostatectomy at least one year prior to study entry date or received perioperative (or peri-XRT) chemotherapy or hormone therapy.
Key inclusion criteria (3 listed)
- Men who have undergone radical prostatectomy, via an open or minimally invasive approach, as primary treatment for a diagnosis of prostate cancer.
- Men who have undergone salvage prostatectomy for recurrence after first-line radiation therapy for prostate cancer.
- Men who underwent prostatectomy at least one year prior to study entry date. Men who received perioperative (or peri-XRT) chemotherapy or hormone therapy are eligible.
Key exclusion criteria (4 listed)
- Men who underwent other primary or secondary treatments for prostate cancer--hormone therapy as only treatment, cryosurgery, adjuvant radiation after prostatectomy
- Men with a history of neurogenic bladder, as demonstrated by previous urodynamics.
- Men with a history of severe outlet obstruction due to longstanding benign prostatic hyperplasia. This will be demonstrated objectively by documentation in the patient's history of preoperative AUA symptom score greater than 15 or a history of urinary retention or nocturia greater than 2 episodes per night.
- Men who underwent additional reconstructive procedures at the time of or subsequent to prostatectomy, including augmentation, urethral sling, or urinary diversion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urodynamics Test90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum. | Procedure or surgery | Prostatectomy, Prostatectomy After Radiation Therapy |
| QuestionnaireSurvey of urinary function and quality-of-life (regarding daily living after surgical treatment for prostate cancer), taking 30 minutes to complete. | Behavioural | Prostatectomy, Prostatectomy After Radiation Therapy |
Primary outcome
Comparison of Urodynamic Changes Related to Radiation Post Salvage Prostatectomy versus Prostatectomy Only
Time frame: Compilation of patient urodynamics test completed in single 90 minute office visit
Comparison of urodynamic changes related to radiation by performing urodynamics (measurement of bladder pressure, electrical activity, and radiographic imaging) in patients post salvage prostatectomy versus prostatectomy only, using a 2-sample t-test to test for differences between the 2 groups of men with respect to urodynamic score.
Results and safety
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Ouida L. Westney, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Urodynamic Changes Related to Radiation Post Salvage Prostatectomy versus Prostatectomy Only (time frame: Compilation of patient urodynamics test completed in single 90 minute office visit). 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 31 Jul 2012.