A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

Benign Prostatic Hyperplasia Clinical Trial

Official title: A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride

Status Terminated

Clinical 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.

Clinical Trial 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:

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

• NCT number: NCT00431626
• Study type: Interventional
• Source: Northwestern University
• Status: Terminated
• Phase: Phase 3
• Start date: October 2006
• Completion date: April 2009