Benign Prostatic HyperplasiaNCT00274417
Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)
A study testing dutasteride in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Urology of Virginia at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- dutasteride
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Urology of Virginia
Norfolk, Virginia, 23510
Urology of Virginia
Virginia Beach, Virginia, 23454
About this study
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)
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.
Read the 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.
- Being tested
- dutasteride
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasterideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Urologic Association Sympton Score
Secondary outcomes (7)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJan 2006
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Urology of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Gregg Eure, MD, Principal investigator, Urology of Virginia Research, Devine-Tidewater Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274417
- Sponsor's protocol ID
- UVA-001
- Status last verified
- Apr 2007
- First submitted
- 9 Jan 2006
- Last updated
- 18 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00274417
- Acronym / sponsor ID
- UVA-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Urology of VirginiaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2006
- Study completion
- May 2009 (estimated)
- First posted
- 10 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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 wash-out of these medications for 3 months prior to screening will be eligible
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dutasteride | Drug | – |
Primary outcome
Change in American Urologic Association Sympton Score
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg Eure, MD principal investigator
Urology of Virginia Research, Devine-Tidewater Urology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dutasteride in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Urology of Virginia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in American Urologic Association Sympton Score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2007.