Comparing Two Treatment Approaches for Benign Prostate Hyperplasia,V2

• Research type

  Research Study

• Full title

  Study FDC114615: Comparative efficacy of DuodartTM plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement.

• IRAS ID

  64703

• Contact name

  Matthew Shaw

• Eudract number

  2010-022111-19

• ISRCTN Number

  n/a

• Research summary

  In the UK there are approximately 1.2 million men diagnosed with moderate to severe benign prostatic hyperplasia (BPH). The symptoms of BPH can have a tremendous impact on the ability to perform daily activities and a man and his partner??s quality of life. Some patients?? BPH will progress and cause urinary retention or require surgery. This study will measure the effect on symptoms of treatment with COMBODART?½ plus lifestyle advice compared to treatment with lifestyle advice and step up therapy to tamsulosin in men with benign prostate hyperplasia (BPH). COMBODART?½ is a newly licensed fixed dose combination capsule which contains the medicines tamsulosin and dutasteride. In this study one group of people will take COMBODART?½ and will be given lifestyle advice and another group will be given lifestyle advice with the possibility of being given tamsulosin if their symptoms do not improve. Men over the age of 50 who have recently been diagnosed with moderate BPH, have an enlarged prostate and have not previously received any treatment for their symptoms may be eligible to take part in this study providing they meet all other study entry criteria. This study will be conducted in hospital urology departments and GP practices. This study will last approximately 2.5 years. Participants in this study will be expected to attend 12 clinic visits over a 2 year period ( 4 weeks). A trans-rectal ultrasound and post-void residual scan will be done at the initial screening visit to determine prostate volume and confirm eligibility. Participants will complete quality of life questionnaires at each visit. Blood and urine samples will be collected at 3 separate visits and digital rectal exam will also be done 3 times during the course of the study. The doctor will perform a nipple and breast area examination at four of the visits.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/H0806/10

• Date of REC Opinion

  3 Mar 2011

• REC opinion

  Further Information Favourable Opinion