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| Sponsor: | Urology of Virginia |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Urology of Virginia |
| ClinicalTrials.gov Identifier: | NCT00274417 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms |
Drug: dutasteride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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) |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | May 2009 |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Men aged ≥ 50 years old 2. Subjects with LUTS due to BPH with:
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 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 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 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 deemed ineligible for the study by the site investigators or the sponsor
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Contacts and Locations| United States, Virginia | |
| Urology of Virginia | |
| Norfolk, Virginia, United States, 23510 | |
| Urology of Virginia | |
| Virginia Beach, Virginia, United States, 23454 | |
| Principal Investigator: | Gregg Eure, MD | Urology of Virginia Research, Devine-Tidewater Urology |
More Information
| ClinicalTrials.gov Identifier: | NCT00274417 History of Changes |
| Other Study ID Numbers: | UVA-001 |
| Study First Received: | January 9, 2006 |
| Last Updated: | April 17, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
Dutasteride 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |