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

Phase 2
30 Years
80 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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.

Inclusion Criteria:

- Diagnosis of localized CaP, based on pathological assessment from biopsy specimens

- No prior or current therapy for CaP or history of cancer except non-melanoma skin

- Scheduled for prostatectomy between 4- 6 weeks (+/-3 days) after start of study agent

- No known history of hepatic or renal disease (LFTs (SGOT/SGPT) > 5.0 x upper limit of
normal as evidenced by impairment of baseline laboratory values, Actual creatinine
clearance of >60 utilizing the Cockcroft-Gault formula (1976), which employs
creatinine measurements and a patient's weight to predict the clearance. The constant
is 1.23 for men.

- Omnivorous diet

- No evidence of prostatitis or urinary tract infection

- Able and willing to give written informed consent

- Currently not using or willing to discontinue any nutritional supplements that
contain soy or soy isoflavones

- Not allergic to study supplements

- Not on antibiotics

- Men who do not consume more than 3 - 4 oz of soy or soy products per week

- Not taking steroid hormones or medications which have known impact on PSA

- Health status cleared by primary MD or urologist

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria:

- Prior history of prostate cancer; Current or prior history of other malignancies
(exceptions include nonmelanoma skin cancer or other cancer with no evidence of tumor
recurrence five years after definitive treatment)

- History of renal or hepatic disease, including history of hepatitis B, C or delta as
evidenced by impairment of baseline laboratory values

- Participation in any other investigational study or use of any other investigational
agents within 30 days of study entry

- History of allergic reactions attributed to soy isoflavones or other compounds of
similar chemical or biologic composition to Novasoy 400® or the inactive components
present in the purified isoflavone and placebo capsules

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or any psychological, familial, sociological or other concomitant
condition that would not allow adequate compliance with the study protocol

- Only African American (a person having origins in any of the black racial groups of
Africa) and Caucasian (a person having origins in any of the original people of
Europe, Middle East, or North Africa) men, as defined by the NIH, will be included in
this study. Since this is an investigation targeting men with CaP, women are not
eligible for the study.

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of Change in Percent Ki-67

Outcome Description:

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.

Outcome Time Frame:

4 - 6 weeks per participant (+/- 3 days)

Safety Issue:


Principal Investigator

Nagi Kumar, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

January 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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