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

Status unconfirmed · Not applicable

Conditions studied: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

In brief

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.

Key facts

Study ID

NCT00274417

Run by

Urology of Virginia

People needed

60

Starts

2006-01-01

Expected to finish

2009-05-01

Last updated by the study team

2007-04-18

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Urology of Virginia — Norfolk, Virginia, United States
• Urology of Virginia — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.