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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01036321
First received: December 17, 2009
Last updated: June 10, 2016
Last verified: June 2016
  Purpose
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:
  • Median Change in Percent Ki-67 From Baseline [ Time Frame: Baseline to post intervention - up to 6 weeks ] [ Designated as safety issue: No ]
    Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.

  • Number of Toxicity Events by Final Attribution and Treatment Arm [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
    Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.


Secondary Outcome Measures:
  • Biomarkers of Disease Progression - Serum PSA [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Median change from baseline to post intervention: Prostatic specific antigen (PSA). All Participants (ALL); Caucasian Men only (CM only); African American Men only (AAM only).

  • Change in Plasma Concentrations of Isoflavone [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Plasma concentrations of isoflavone: Genistein from baseline to post intervention by study arm.

  • Biomarkers of Disease Progression - Estradiol [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).

  • Biomarkers of Disease Progression - Free Testosterone [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).

  • Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).

  • Biomarkers of Disease Progression - IGF-1 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).

  • Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG) [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).

  • Biomarkers of Disease Progression - Total Testosterone [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).


Enrollment: 71
Study Start Date: December 2009
Estimated Study Completion Date: July 2017
Primary Completion Date: June 2014 (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
Placebo.
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of localized prostate cancer (PCa), based on pathological assessment from biopsy specimens
  • No prior or current therapy for PCa 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 prostatic specific antigen (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 PCa, women are not eligible for the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01036321

Locations
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
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Nagi Kumar, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01036321     History of Changes
Other Study ID Numbers: MCC-15835  IRB 107980  1P20MD003375-01 
Study First Received: December 17, 2009
Results First Received: June 18, 2015
Last Updated: June 10, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2016