Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness
Status:
Completed
Trial end date:
2018-04-16
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)