Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute Identifier:
First received: December 17, 2009
Last updated: October 31, 2014
Last verified: October 2014

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.

Condition Intervention Phase
Prostate Cancer
Drug: Purified isoflavones
Drug: Methyl cellulose blend
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action Between African American and Caucasian Men

Resource links provided by NLM:

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Incidence of Change in Percent Ki-67 [ Time Frame: 3 - 6 weeks per participant (+/- 3 days) ] [ Designated as safety issue: No ]
    Efficacy: Change in percent Ki-67 evaluated in prostate cancer tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.

  • Incidence of Adverse Events (AEs) [ Time Frame: 3 - 6 weeks per participant ] [ Designated as safety issue: Yes ]
    Safety: Incidence and severity of AEs occurring during intervention with either 20 mg purified isoflavones bid or placebo.

Secondary Outcome Measures:
  • Biomarkers of Disease Progression. [ Time Frame: 3 - 6 weeks per participant ] [ Designated as safety issue: No ]
    Biomarkers of disease progression: Serum steroid hormones, prostatic specific antigen (PSA) 0, apoptotic index, Tumor Volume (TV), Gleason Score (GS); Symptoms including Lower Urinary Tract Symptoms (LUTS).

  • Expression Levels of Isoflavone Participants [ Time Frame: 3 - 6 weeks per participant ] [ Designated as safety issue: No ]
    Mechanism: To determine if purified isoflavones at a dose of 40 mg daily (20 mg bid) vs. placebo results in decreased expression of the androgen receptor and increased expression levels of forkhead box O1 (FOXO1) and its target genes from baseline to prostatectomy in prostate cancer patients and whether the treatment effect of the study agent in the AR-FOXO axis is more profound in African American patients as compared to the Caucasian group and correlates inversely with ERα/ERβ ratio.

Enrollment: 71
Study Start Date: December 2009
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Purified Isoflavones
Soy-based isoflavone concentrate with methyl cellulose blend filler. 40 mg daily.
Drug: Purified isoflavones
Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily
Other Names:
  • Novasoy 400
  • Avicel PH105
Placebo Comparator: Methyl cellulose blend
Drug: Methyl cellulose blend
Placebo - Take 2 capsules daily
Other Name: Avicel PH105

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.


Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 cancer
  • Scheduled for prostatectomy between 3- 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01036321

United States, Florida
University of Florida & Shands Medical Center - Jacksonville
Jacksonville, Florida, United States, 32209
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
James A. Haley VA Hospital
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: Nagi Kumar, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT01036321     History of Changes
Other Study ID Numbers: MCC-15835, IRB 107980, 1P20MD003375-01
Study First Received: December 17, 2009
Last Updated: October 31, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on November 24, 2014