Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma
Primary Purpose
Prostate Cancer, Post-Brachytherapy Bladder Outlet Obstruction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Memokath 028SW Urethral Stent
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, brachytherapy, urethral stenting
Eligibility Criteria
Inclusion Criteria: eligible for prostate seed implant 50 years of age or older able to give informed consent Exclusion Criteria: presence of any other urologic implant, including stents,penile prosthesis or artificial sphincter history of transurethral resection of prostate (TURP)procedure presence of urethral diverticuli presence of urethral strictures presence of bladder calculi or tumors prostatic urethra is less than 2.5 cm or greater than 6.5 cm inability to participate in study activities due to physical or mental limitations inability or unwillingness to return for all the required follow-up visits
Sites / Locations
- Cleveland Clinic Foundation
Outcomes
Primary Outcome Measures
Morbidities assessed on RTOG Morbidity Scale weekly for 12 weeks after PI then biweekly for next 12 weeks
Clinic visits at 2 weeks, 3 months and 6 months; physical exam to include urine flow rate, post-void residual and urinalysis
CT at 1 month post-brachytherapy
Device removal at 6 months (earlier if adverse event or patient wishes to discontinue trial)
Cystoscopy to assess urethra after stent removal
Secondary Outcome Measures
AUA score to assess severity of urinary symptoms
Full Information
NCT ID
NCT00252941
First Posted
November 14, 2005
Last Updated
December 20, 2010
Sponsor
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00252941
Brief Title
Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma
Official Title
The Role Of Prophylactic Urethral Stenting With Memokath® 028SW in Patients Undergoing Prostate 125I Seed Implants For Prostate Carcinoma: A Phase I/II Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Cleveland Clinic
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the feasibility, safety, and efficacy of the Memokath® 028SW stent to prevent urinary obstructive symptoms (difficulty urinating) when used after prostate seed implantation for the treatment of localized prostate cancer.
Detailed Description
Image-guided transperineal permanent prostate brachytherapy (PI) is an accepted curative treatment option for patients with early stage prostate cancer. Multiple reports have defined its efficacy and shown it to be superior to antecedent trans-abdominal techniques. In addition, the efficacy of PI has been shown to be similar to radical retropubic prostatectomy (RRP) and external beam radiotherapy (EBRT). These positive results, however, are gained at the expense of toxicity. The most notable toxicity is associated with the urinary system. The most severe side effect of PI is urinary retention requiring intermittent self-catheterization (ISC).
The reported rate of severe urinary retention following PI is ~10%. Most of these patients can be managed with ISC and alpha-blockers for a few weeks. Although this is generally a temporary phenomenon, a small percentage will eventually require surgical intervention to permit urinary flow. This is a major concern for patients undergoing PI, but should not be a reason to avoid this form of curative treatment.
The use of implantable stents has been successful in BPH. The Memokath® device has been shown to decrease the International Prostate Symptom Score from a mean of 20.3 to 8.2 in the first 3 months after stent placement in patients with bladder outlet obstruction unable to undergo TURP. Few experience side-effects with pain in 3%, hematuria in 3%, incontinence in 6%, and infection in 6%. A multicenter randomized control trial is currently underway assessing the use of this device in patients with recurrent urethral strictures.
Urethral stents have been used with some success in patients with post-brachytherapy bladder outlet obstruction. Five patients, who could not tolerate alpha-blockers or clean intermittent catheterization, received UroLume urethral stents following one or more episodes of urinary retention. All patients were able to void immediately after stent placement. No patients developed incontinence after the stent placement. The main complaints following UroLume® stent placement were urethral bleeding, referred pain at the head of the penis, and dysuria. These symptoms required stent removal in 2 out of the 5 patients. In another study, five patients received SpannerTM urethral stents following significant urinary symptoms after prostate brachytherapy. All patients were able to void spontaneously with no post-void residual volume of urine. Flow rates increased and the International Prostate Symptom Score decreased from a mean of 25.2 to 10 (p=0.03). However, two patients experienced pain, which required removal of the stent.
Given that few patients have experienced side effects with the Memokath® urethral stent in bladder outlet obstruction, we wish to assess the toxicity associated with this stent in a post-brachytherapy setting. In addition, we would like to assess its efficacy when used prophylactically in reducing bladder outlet obstruction following prostate brachytherapy and its impact on the AUA score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Post-Brachytherapy Bladder Outlet Obstruction
Keywords
prostate cancer, brachytherapy, urethral stenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Memokath 028SW Urethral Stent
Primary Outcome Measure Information:
Title
Morbidities assessed on RTOG Morbidity Scale weekly for 12 weeks after PI then biweekly for next 12 weeks
Title
Clinic visits at 2 weeks, 3 months and 6 months; physical exam to include urine flow rate, post-void residual and urinalysis
Title
CT at 1 month post-brachytherapy
Title
Device removal at 6 months (earlier if adverse event or patient wishes to discontinue trial)
Title
Cystoscopy to assess urethra after stent removal
Secondary Outcome Measure Information:
Title
AUA score to assess severity of urinary symptoms
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eligible for prostate seed implant
50 years of age or older
able to give informed consent
Exclusion Criteria:
presence of any other urologic implant, including stents,penile prosthesis or artificial sphincter
history of transurethral resection of prostate (TURP)procedure
presence of urethral diverticuli
presence of urethral strictures
presence of bladder calculi or tumors
prostatic urethra is less than 2.5 cm or greater than 6.5 cm
inability to participate in study activities due to physical or mental limitations
inability or unwillingness to return for all the required follow-up visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay P Ciezki, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma
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