Benign Prostatic HyperplasiaPhase 3NCT00431626
A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
A Phase 3 study testing Dutasteride (Avodart) in people with Benign Prostatic Hyperplasia, run by Northwestern University.
Trial summary
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Dutasteride (Avodart)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient is a male at least 50 years of age.
- The patient's peak urinary flow rate is at least 4 ml/sec, but not greater than 15 ml/sec, and the voided volume is at least 125 ml.
- Prostate volume must be greater than 30 grams
- The AUA-SI is greater than or equal to 9.
- Patient must be scheduled for a Laser TURP or eligible to be scheduled for Laser TURP
- Patient must be able to complete the study requirements prior to the scheduled laser TURP.
- The patient has signed the informed consent prior to the performance of any study procedures.
Who cannot join
- The patient has had any prior surgical intervention for BPH.
- The patient is receiving any intervention for prostate disease (either medical or surgical) or is presently enrolled in any study protocol.
- The patient has had a previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to dutasteride.
- The patient has taken an alpha-1 blocker within 1 month of randomization.
- The patient has taken finasteride or dutasteride within 3 months of randomization.
- The patient has taken phenylephrine, pseudoephedrine, imipramine, and an anticholinergic or cholinergic medication within 4 weeks of the screening visit.
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- The patient has taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids.
- The patient has an inability to urinate.
- The patient has clinically significant renal or hepatic impairment (i.e., creatinine greater than 2.0 mg/dl or AST greater than 1.5 times the upper limit of normal).
- The patient has a PSA level greater than 10 ug/ml (Hybritech).
- The patient requires the daily use of a pad or device for incontinence.
- The patient has had an episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
- The patient has a penile prosthesis or artificial urinary sphincter.
- The patient has a history or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, prior surgery for BPH, or bladder neck obstruction.
- The patient has an active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within two weeks prior to the first screening visit.
- The patient has known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
- The patient has had documented bacterial prostatitis within the past year.
- The patient has had two documented urinary tract infections of any type in the past year. A urinary tract infection is defined as >100,000 colonies per ml urine from midstream clean catch or catheterized specimen.
- The patient has a severe bleeding disorder that makes laser TURP impossible.
- The patient must be able to stop any anticoagulant, NSAID or anti-platelet for 7 days prior to the laser TURP.
- The patient has had cancer that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A patient is considered cured if there has been no evidence of cancer within five years of randomization.
- The patient has a diagnosis of a thought disorder (i.e., schizophrenia, bipolar disorder)
- The patient has any serious medical condition likely to impede successful completion of the study.
- The patient has a defibrillator that cannot be deactivated during laser TURP treatment.
- A bladder neck to verumontanum distance which is less than 30mm in length as measured by flexible cystoscopy and a total prostate volume <25 ml or >110 ml as measured by prostate volume ellipsoid formula during TRUS.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.
Read the detailed description
Benign Prostatic Hyperplasia (BPH) is the most common neoplastic condition afflicting middle-aged and elderly men. BPH is a non-cancerous condition in which the prostate becomes enlarged which can cause lower urinary tract symptoms (LUTS). These symptoms include: frequency, urgency, weak urinary stream, difficulty starting or stopping to urinate and feeling the need to urinate even after just finishing urinating.
One of the minimally invasive treatments for BPH is a Laser TURP. The men going into this study would be planning on having a Holmium Laser TURP at Northwestern Memorial Hospital in Chicago, Illinois.
Another treatment for BPH is the use of a class of drugs called 5-Alpha Reductase Inhibitors (5ARI). Dutasteride is a 5ARI that has been approved by the U.S. Food and drug Administration (FDA) for the treatment of BPH.
Each participant in this study will be randomized into ONE of the treatment groups below:
- Laser TURP combined with Dutasteride
- Laser TURP combined with placebo.
This study is double-masked which means neither the participant, nor the study staff will know who is receiving active study drug or placebo. There will be a 50% chance of receiving the study drug, Dutasteride, and a 50% chance of receiving a placebo.
Dutasteride or it's placebo comes as a 0.5mg capsule to be taken by mouth once a day at bedtime.
There will be a screening period that may last up to 8 weeks. It will include:
- There will be 2 or 3 screening visits to the clinic with each visit lasting approximately 2.5 to 3 hours.
- Each participant will be asked to complete various forms and questionnaires regarding their lower urinary tract symptoms and how they effect them and their sexual function.
- No study drug will be taken during this time.
- The Laser TURP at Northwestern Memorial Hospital will be scheduled.
If each requirement has been met and it is determined that the participant is eligible to participate in this trial the participant will come to the clinic for a randomization visit.
At this visit the participant will be randomized into one of the two treatment groups noted above. Randomization is like a flip of a coin and neither the participant, nor the study staff chooses which treatment will be given.
Each participant will start taking the study drug everyday for six weeks before undergoing the Laser TURP and will continue taking the study drug every day for one year after the Laser TURP.
If the Laser TURP requires having a catheter in place, the participant will be seen by the urology clinic staff for follow up visits for this catheter. This follow up schedule may require weekly visits.
There will be follow up visits with the research staff. The participant will be asked to come to the research clinic every three months for one year. Each follow up visit will last approximately 1.5 hours.
A final visit will take place at one year. This will be identical to the first screening visit. This visit will last approximately 2 hours.
If the participant decides to withdraw from this study early he will be asked to come into the office for an early withdrawal visit.
Please note: The above detailed information regarding this research study is not in it's entirety. All of the above and more will be discussed in complete detail upon meeting with a research staff member or by calling the contact person mentioned in this protocol registration below.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Dutasteride (Avodart), Placebo
- Keywords
- Benign, Prostatic, Hyperplasia, Lower, Urinary, Track, Symptoms, Laser, Transurethral, Prostate
- Medical subject headings
- Prostatic Hyperplasia, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dutasteride (Avodart)Drug
PlaceboDrug
Placebo before and after treatment of TURP
| Study group | Role | What they receive |
|---|---|---|
| Laser TURP with dutasteride | Experimental | Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient Receives: Drug: Dutasteride (Avodart) |
| Laser TURP with placebo | Placebo comparator | Prior to and after standard treatment with laser TURP, placebo is applied to each patient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Kevin McVary, Northwestern University
- Investigators
- Kevin T. McVary, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431626
- Sponsor's protocol ID
- 0348-040
- Status last verified
- Oct 2015
- First submitted
- 2 Feb 2007
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride
- ClinicalTrials.gov ID
- NCT00431626
- Acronym / sponsor ID
- 0348-040
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign, Prostatic, Hyperplasia, Lower, Urinary, Track, Symptoms, Laser
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Posted 1 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.
Detailed description
Benign Prostatic Hyperplasia (BPH) is the most common neoplastic condition afflicting middle-aged and elderly men. BPH is a non-cancerous condition in which the prostate becomes enlarged which can cause lower urinary tract symptoms (LUTS). These symptoms include: frequency, urgency, weak urinary stream, difficulty starting or stopping to urinate and feeling the need to urinate even after just finishing urinating.
One of the minimally invasive treatments for BPH is a Laser TURP. The men going into this study would be planning on having a Holmium Laser TURP at Northwestern Memorial Hospital in Chicago, Illinois.
Another treatment for BPH is the use of a class of drugs called 5-Alpha Reductase Inhibitors (5ARI). Dutasteride is a 5ARI that has been approved by the U.S. Food and drug Administration (FDA) for the treatment of BPH.
Each participant in this study will be randomized into ONE of the treatment groups below:
- Laser TURP combined with Dutasteride
- Laser TURP combined with placebo.
This study is double-masked which means neither the participant, nor the study staff will know who is receiving active study drug or placebo. There will be a 50% chance of receiving the study drug, Dutasteride, and a 50% chance of receiving a placebo.
Dutasteride or it's placebo comes as a 0.5mg capsule to be taken by mouth once a day at bedtime.
There will be a screening period that may last up to 8 weeks. It will include:
- There will be 2 or 3 screening visits to the clinic with each visit lasting approximately 2.5 to 3 hours.
- Each participant will be asked to complete various forms and questionnaires regarding their lower urinary tract symptoms and how they effect them and their sexual function.
- No study drug will be taken during this time.
- The Laser TURP at Northwestern Memorial Hospital will be scheduled.
If each requirement has been met and it is determined that the participant is eligible to participate in this trial the participant will come to the clinic for a randomization visit.
At this visit the participant will be randomized into one of the two treatment groups noted above. Randomization is like a flip of a coin and neither the participant, nor the study staff chooses which treatment will be given.
Each participant will start taking the study drug everyday for six weeks before undergoing the Laser TURP and will continue taking the study drug every day for one year after the Laser TURP.
If the Laser TURP requires having a catheter in place, the participant will be seen by the urology clinic staff for follow up visits for this catheter. This follow up schedule may require weekly visits.
There will be follow up visits with the research staff. The participant will be asked to come to the research clinic every three months for one year. Each follow up visit will last approximately 1.5 hours.
A final visit will take place at one year. This will be identical to the first screening visit. This visit will last approximately 2 hours.
If the participant decides to withdraw from this study early he will be asked to come into the office for an early withdrawal visit.
Please note: The above detailed information regarding this research study is not in it's entirety. All of the above and more will be discussed in complete detail upon meeting with a research staff member or by calling the contact person mentioned in this protocol registration below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser TURP with dutasteride | Experimental | Drug: Dutasteride (Avodart)Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient |
| Laser TURP with placebo | Placebo comparator | Drug: PlaceboPrior to and after standard treatment with laser TURP, placebo is applied to each patient |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is a male at least 50 years of age.
- The patient's peak urinary flow rate is at least 4 ml/sec, but not greater than 15 ml/sec, and the voided volume is at least 125 ml.
- Prostate volume must be greater than 30 grams
- The AUA-SI is greater than or equal to 9.
- Patient must be scheduled for a Laser TURP or eligible to be scheduled for Laser TURP
Key exclusion criteria (25 listed)
- The patient has had any prior surgical intervention for BPH.
- The patient is receiving any intervention for prostate disease (either medical or surgical) or is presently enrolled in any study protocol.
- The patient has had a previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to dutasteride.
- The patient has taken an alpha-1 blocker within 1 month of randomization.
- The patient has taken finasteride or dutasteride within 3 months of randomization.
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 (Avodart) | Drug | Laser TURP with dutasteride |
| PlaceboPlacebo before and after treatment of TURP | Drug | Laser TURP with placebo |
Primary outcome
Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
Time frame: one year
AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kevin T. McVary, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dutasteride (Avodart) in people with Benign Prostatic Hyperplasia, run by Northwestern University.
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 7 inclusion and 25 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: stopped early, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index (time frame: one year). 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 28 Oct 2015.