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Study Summary
No. 2006-0384:.......Prostate......Ouida L. Westney......Urology
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Study Summary Title
Study Summary
Number:		2006-0384
Study Title:Comparison of Urodynamic Evaluation in Post-Radiation Salvage Prostatectomy versus Prostatectomy-only Patients
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Physician New Patient Referral
Name:Ouida L. WestneyPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:UrologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-7575
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:N/A
Phase of Study:N/AReturn
Visit:		There will be only one visit to MDACC by each subject.
Treatment
Agents:		NoneHome Care:No treatments will be required to be given at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Each subject will require a visit of several hours in the clinic for testing of
urodynamics (approximately 90 minutes) and administration of the questionnaire
(approximately 30 minutes).
Description/
Intervention:		The goal of this clinical research study is to compare bladder and voiding
function of men who have had a prostatectomy alone or who have had a
prostatectomy after radiation therapy.
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Study Objectives / Outcomes
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. We will also look at secondary objective urodynamic measures, such as bladder capacity, to assess for a difference.
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Study Status Information
Study Activation / Registration Date:08/17/2007
IRB Review and Approval Date:06/29/2007
Study Type:Observational
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Men who have undergone radical prostatectomy, via an open or minimally invasive approach, as primary treatment for a diagnosis of prostate cancer.

2) Men who have undergone salvage prostatectomy for recurrence after first-line radiation therapy for prostate cancer.

3) 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.
Exclusion Criteria:1) Men who underwent other primary or secondary treatments for prostate cancer--hormone therapy as only treatment, cryosurgery, adjuvant radiation after prostatectomy

2) Men with a history of neurogenic bladder, as demonstrated by previous urodynamics.

3) 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.

4) Men who underwent additional reconstructive procedures at the time of or subsequent to prostatectomy, including augmentation, urethral sling, or urinary diversion.
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Links
Registration Number: NCT00901420
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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