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A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

Primary Purpose

Benign Prostatic Hyperplasia

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dutasteride (Avodart)
Placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign, Prostatic, Hyperplasia, Lower, Urinary, Track, Symptoms, Laser, Transurethral, Prostate

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Laser TURP with dutasteride

    Laser TURP with placebo

    Arm Description

    Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient

    Prior to and after standard treatment with laser TURP, placebo is applied to each patient

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2007
    Last Updated
    October 6, 2015
    Sponsor
    Northwestern University
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00431626
    Brief Title
    A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
    Official Title
    A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    Low enrollment
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia
    Keywords
    Benign, Prostatic, Hyperplasia, Lower, Urinary, Track, Symptoms, Laser, Transurethral, Prostate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laser TURP with dutasteride
    Arm Type
    Experimental
    Arm Description
    Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
    Arm Title
    Laser TURP with placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Prior to and after standard treatment with laser TURP, placebo is applied to each patient
    Intervention Type
    Drug
    Intervention Name(s)
    Dutasteride (Avodart)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo before and after treatment of TURP
    Primary Outcome Measure Information:
    Title
    Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
    Description
    AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
    Time Frame
    one year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin T. McVary, MD
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

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