A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
A Clinical Trial Comparing Laser TURP With and Without 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.
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:

 1. Laser TURP combined with Dutasteride

 2. 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.
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.