- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00274417
Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)
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 Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Virginia
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Norfolk, Virginia, United States, 23510
- Urology of Virginia
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Virginia Beach, Virginia, United States, 23454
- Urology of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in American Urologic Association Sympton Score
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Secondary Outcome Measures
Outcome Measure |
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Change in BPH Quality of Life
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Change in urinary flow rate
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Change in post void residual
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PVP operation time, wattage use, estimated blood loss
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Post-operative catheter time
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Incidence of post-operative dysuria and hematuria
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Incidence of expected and unexpected adverse events following PVP
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregg Eure, MD, Urology of Virginia Research, Devine-Tidewater Urology
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urological Manifestations
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Lower Urinary Tract Symptoms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 5-alpha Reductase Inhibitors
- Dutasteride
Other Study ID Numbers
- UVA-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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