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Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dutasteride
Sponsored by
Urology of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 1. Men aged ≥ 50 years old 2. Subjects with LUTS due to BPH with: AUA SI score ≥ 12 at baseline Qmax ≤ 15 mL/sec (on at least 125 mL) Symptoms for ≥ 3 months 3. Subjects with prostate volume ≥ 30 grams 4. Subjects who are appropriate surgical candidates for Photoselective Vaporization of the Prostate (PVP) as determined by a study investigator 5. Subjects able to swallow and retain oral medication 6. Subjects able to comply with study protocol 7. Subjects able to read and write (to complete the self-administered AUA SI) 8. Subjects who sign the approved Informed Consent Form for the study Exclusion Criteria: Subjects who have previously undergone a surgical treatment for BPH including but not limited to TURP, TUNA, TUIP, thermotherapy, prostatic stent, dilation balloon, etc. Subjects with a history of prostate cancer Subjects with a history of bladder or testicular cancer in the past 5 years  Subjects who have been cancer-free for at least 5 years will be eligible  Subjects with a history of superficial bladder cancer will not be excluded Subjects who have received radiation to the pelvis or prostate or radical surgery to the pelvic area Subjects with persistent gross hematuria, current symptomatic prostatitis Subjects with neurogenic bladder and/or sphincter abnormalities for any reason including Parkinson's disease, multiple sclerosis, stroke, or diabetes Subjects who have used any 5 α-reductase inhibitors in the past 3 months.  Subjects who wash-out of these medications for 3 months prior to screening will be eligible Subjects taking alpha-blockers within 2 weeks prior to randomization.  Subjects must be off of alpha blockers at the time of randomization for the measurement of AUA Symptom Score, QoL Score, flow rate, post void residual, etc. In the rare case a patient goes into retention during the 3 month period between randomization and PVP, they will be allowed to resume their alpha blocker until the PVP since no outcomes are measured during this period. They will be required to discontinue the alpha blocker after they have surgery Subjects on an unstable regimen of antidepressants, anticholinergics, androgens, or herbal supplements including phyto-sterols (such as saw palmetto)  Subjects who are on a stable regimen of the above medications for at least 1 month prior to screening and are willing to stay on the same dose for the duration of the study will be eligible Subjects on an unstable regimen of beta-blockers, antihistamines, anticonvulsants, antispasmodics, or other medications known to affect the clinical symptoms of BPH  Subjects who are on a stable regimen of the above medications for at least 4 months prior to screening and are willing to stay on the same dose for the duration of the study will be eligible Subjects with a post void residual > 350 mL Subjects with a known hypersensitivity to 5α-reductase inhibitors PSA > 10  Subjects with a PSA between 4 and 10 with a negative prostate biopsy and deemed at low risk for prostate cancer by the investigator Subjects with serum creatinine >1.5 x the upper limit, ALT > 2 x the upper limit, AST > 2 x the upper limit, ALP > 2 x the upper limit, or bilirubin > 1.5 x the upper limit for normal Subjects treated in the last 30 days with another investigational product or currently participating in another study with an investigational drug or procedure Subjects deemed ineligible for the study by the site investigators or the sponsor -

Sites / Locations

  • Urology of Virginia
  • Urology of Virginia

Outcomes

Primary Outcome Measures

Change in American Urologic Association Sympton Score

Secondary Outcome Measures

Change in BPH Quality of Life
Change in urinary flow rate
Change in post void residual
PVP operation time, wattage use, estimated blood loss
Post-operative catheter time
Incidence of post-operative dysuria and hematuria
Incidence of expected and unexpected adverse events following PVP

Full Information

First Posted
January 9, 2006
Last Updated
April 17, 2007
Sponsor
Urology of Virginia
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00274417
Brief Title
Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)
Official Title
A Randomized, Placebo-Controlled, Double-Blind Study of the Use of Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Urology of Virginia
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study is for individuals electing to have GreenLight Photoselective Vaporization of the Prostate (PVP) to treat symptoms from an enlarged prostate gland. The purpose of this research study is to evaluate the safety and effectiveness of the medication dutasteride as compared to placebo (an inactive substance) for improving surgical and long-term outcomes of PVP. Dutasteride is approved by the United States Food and Drug Administration (FDA) for the treatment of symptoms from an enlarged prostate gland. The use of dutasteride to improve the outcomes of PVP is investigational. The study will last for approximately 15 months and will involve 6 visits.
Detailed Description
The purpose of the study is to assess the effects of dutasteride on the outcomes and QoL of patients undergoing GreenLight Photoselective Vaporization of the Prostate. PVP is a growing, outpatient surgical treatment for BPH. The addition of dutasteride may potentially improve both the short and long term outcomes. Use peri-operatively may improve visibility during surgery, shorten operative time, lessen bleeding both intra and post-operatively and hasten post-op recovery. Continued use long-term (12 months following the procedure) may improve overall symptomatic scores as combination therapy with PVP. The addition of dutasteride to PVP may decrease the occasional occurrence of continued post-op irritative symptoms and lessen the likelihood of the need for re-catheterization with overall improvement in quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dutasteride
Primary Outcome Measure Information:
Title
Change in American Urologic Association Sympton Score
Secondary Outcome Measure Information:
Title
Change in BPH Quality of Life
Title
Change in urinary flow rate
Title
Change in post void residual
Title
PVP operation time, wattage use, estimated blood loss
Title
Post-operative catheter time
Title
Incidence of post-operative dysuria and hematuria
Title
Incidence of expected and unexpected adverse events following PVP

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Men aged ≥ 50 years old 2. Subjects with LUTS due to BPH with: AUA SI score ≥ 12 at baseline Qmax ≤ 15 mL/sec (on at least 125 mL) Symptoms for ≥ 3 months 3. Subjects with prostate volume ≥ 30 grams 4. Subjects who are appropriate surgical candidates for Photoselective Vaporization of the Prostate (PVP) as determined by a study investigator 5. Subjects able to swallow and retain oral medication 6. Subjects able to comply with study protocol 7. Subjects able to read and write (to complete the self-administered AUA SI) 8. Subjects who sign the approved Informed Consent Form for the study Exclusion Criteria: Subjects who have previously undergone a surgical treatment for BPH including but not limited to TURP, TUNA, TUIP, thermotherapy, prostatic stent, dilation balloon, etc. Subjects with a history of prostate cancer Subjects with a history of bladder or testicular cancer in the past 5 years  Subjects who have been cancer-free for at least 5 years will be eligible  Subjects with a history of superficial bladder cancer will not be excluded Subjects who have received radiation to the pelvis or prostate or radical surgery to the pelvic area Subjects with persistent gross hematuria, current symptomatic prostatitis Subjects with neurogenic bladder and/or sphincter abnormalities for any reason including Parkinson's disease, multiple sclerosis, stroke, or diabetes Subjects who have used any 5 α-reductase inhibitors in the past 3 months.  Subjects who wash-out of these medications for 3 months prior to screening will be eligible Subjects taking alpha-blockers within 2 weeks prior to randomization.  Subjects must be off of alpha blockers at the time of randomization for the measurement of AUA Symptom Score, QoL Score, flow rate, post void residual, etc. In the rare case a patient goes into retention during the 3 month period between randomization and PVP, they will be allowed to resume their alpha blocker until the PVP since no outcomes are measured during this period. They will be required to discontinue the alpha blocker after they have surgery Subjects on an unstable regimen of antidepressants, anticholinergics, androgens, or herbal supplements including phyto-sterols (such as saw palmetto)  Subjects who are on a stable regimen of the above medications for at least 1 month prior to screening and are willing to stay on the same dose for the duration of the study will be eligible Subjects on an unstable regimen of beta-blockers, antihistamines, anticonvulsants, antispasmodics, or other medications known to affect the clinical symptoms of BPH  Subjects who are on a stable regimen of the above medications for at least 4 months prior to screening and are willing to stay on the same dose for the duration of the study will be eligible Subjects with a post void residual > 350 mL Subjects with a known hypersensitivity to 5α-reductase inhibitors PSA > 10  Subjects with a PSA between 4 and 10 with a negative prostate biopsy and deemed at low risk for prostate cancer by the investigator Subjects with serum creatinine >1.5 x the upper limit, ALT > 2 x the upper limit, AST > 2 x the upper limit, ALP > 2 x the upper limit, or bilirubin > 1.5 x the upper limit for normal Subjects treated in the last 30 days with another investigational product or currently participating in another study with an investigational drug or procedure Subjects deemed ineligible for the study by the site investigators or the sponsor -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg Eure, MD
Organizational Affiliation
Urology of Virginia Research, Devine-Tidewater Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology of Virginia
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

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Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)

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