Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action Between African American and Caucasian Men
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 (4-6 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 4-6 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 4-6 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Incidence of Change in Percent Ki-67
Efficacy: Change in percent Ki-67 evaluated in prostate cancer tissue specimens after 4-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.
4 - 6 weeks per participant (+/- 3 days)
Nagi Kumar, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|James A. Haley VA Hospital||Tampa, Florida 33612|
|University of Florida & Shands Medical Center - Jacksonville||Jacksonville, Florida 32209|