Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

Benign Prostate Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861588
• Other study ID #: CUHK4453/05M
• Status: Completed
• Phase: N/A
• First received: March 12, 2009
• Last updated: March 12, 2009
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: March 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that produces significant morbidity and hea1th care costs. It is likely that BPH is just as common among Chinese men. Debate exists as to whether currently available surgical and pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this condition. Evidence suggests that the consumption of soy isoflavones is related to lower rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies may include better patient compliance, improved safety and lower cost. Despite the fact that soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism of action, no randomised control trial has been performed using isoflavones to treat BPH. Therefore, a randomised control trial is proposed to test the tolerability and effectiveness of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will be reviewed every three months with maximal urine flow rate, international prostate symptoms score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize that this intervention will reduce lower urinary tract symptoms and slow the progression of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Chinese ethnicity

• Age between 45-85 years

• Diagnosed to have watchful waiting BPH (Qmax< 15 ml/sec together with a voided volume of more than 150 mls)

• Not on any concurrent alternative medications for BPH

• Mentally capable to give informed written consent and willing to comply with study requirements

Exclusion Criteria:

• Prefers to have conventional medical or surgical treatment for BPH

• Concurrent treatment for unstable chronic diseases including unstable angina, poorly controlled DM (HbA1c >7.5), less than 3 months post-MI or frequent exacerbation of COPD (more than 3x in the last year)

• Known to have prostate cancer or kidney and/or liver failure

• Urinary symptoms due to known causes other than BPH including neurogenic bladder, urinary tract infection, bladder cancer, bladder stone, urethral stricture

• Previous history of prostatic surgery

• Illiterate or having difficulty in filling in a patient diary

Study Design

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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• isoflavones (Soylife 25)
40mg of soy isoflavones capsule (once daily)
• placebo
starch placebo

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	School of Pharmacy, CUHK

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary safety endpoint is tolerability i.e. discontinuation due to an adverse event. The primary efficacy outcome will be an improvement in the urine flow rate by at least 2ml/sec after 12 months treatment when compared to placebo.		12 months	Yes
Primary	The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in the International Prostate Symptom Score (IPSS) and Sf-36 respectively.		12 months	No
Secondary	The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in IPSS and Sf-36 respectively.		12 months	Yes