CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
Purified isoflavones +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01036321
NCT01036321Phase 2Completed

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

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 21, 2009·Updated Aug 6, 2019

In Brief

A Phase 2 clinical trial evaluating Purified isoflavones and Methyl cellulose blend for Prostate Cancer. Completed, enrolled 71 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2009
Enrollment StartDec 11, 2009
Primary CompletionJun 26, 2014
Study CompletionApr 16, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.5 years ago

Interventions

Purified isoflavonesdrug

Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily

Methyl cellulose blenddrug

Placebo - Take 2 capsules daily