NCT01036321

Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness

Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action Between African American and Caucasian Men

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it. We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones are able to slow the progression of prostate cancer, and the mechanism of action of purified isoflavones. If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study, this will also be a safe way of treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer in the future.

Detailed description

Patients will need to take two (2) capsules daily, one with their breakfast and one with their dinner. On the day prior or the day that patients are coming in for their pre-operative surgery blood work, we ask that they take the second dose with lunch, if their appointment is in the afternoon. At the start of the study and at the end of the study (3-6 weeks), patients will undergo interviews, complete questionnaires, and have lab tests to determine if this drug is effective to reduce progression of prostate cancer and is safe to use. Patients will also receive a multivitamin/mineral supplement for the 3-6 weeks that they are on this study and will be required to take one (1) every day. It is required that patients not take any other vitamin/mineral or herbal preparation containing isoflavones and avoid eating or drinking soy products. We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks (+/- 3 days) from start of study agent. In addition to their first visit, patients will be required to come in the day of the surgery for prostatectomy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Purified isoflavones	Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily
DRUG	Methyl cellulose blend	Placebo - Take 2 capsules daily

Timeline

• Start date: 2009-12-11
• Primary completion: 2014-06-26
• Completion: 2018-04-16
• First posted: 2009-12-21
• Last updated: 2019-08-06
• Results posted: 2015-08-13

Locations

3 sites across 1 country: United States