Urodynamic Evaluation in Post-radiation Salvage Prostatectomy Patients

Stopped early

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00901420

Run by

M.D. Anderson Cancer Center

People needed

2

Starts

2007-06-01

Expected to finish

2010-05-01

Last updated by the study team

2012-07-31

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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