- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01036321
Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness
Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action Between African American and Caucasian Men
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
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Jacksonville, Florida, United States, 32209
- University of Florida & Shands Medical Center - Jacksonville
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Tampa, Florida, United States, 33612
- James A. Haley VA Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Purified Isoflavones
Soy-based isoflavone concentrate with methyl cellulose blend filler.
40 mg daily.
|
Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily
Other Names:
|
Placebo Comparator: Methyl cellulose blend
Placebo.
|
Placebo - Take 2 capsules daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Change in Percent Ki-67 From Baseline
Time Frame: Baseline to post intervention - up to 6 weeks
|
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.
|
Baseline to post intervention - up to 6 weeks
|
Number of Toxicity Events by Final Attribution and Treatment Arm
Time Frame: Up to 6 weeks
|
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.
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers of Disease Progression - Serum PSA
Time Frame: Up to 6 weeks
|
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).
|
Up to 6 weeks
|
Change in Plasma Concentrations of Isoflavone
Time Frame: Up to 6 weeks
|
Plasma concentrations of isoflavone: Genistein from baseline to post intervention by study arm.
|
Up to 6 weeks
|
Biomarkers of Disease Progression - Estradiol
Time Frame: Up to 6 weeks
|
Median change from baseline to post intervention.
Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
|
Up to 6 weeks
|
Biomarkers of Disease Progression - Free Testosterone
Time Frame: Up to 6 weeks
|
Median change from baseline to post intervention.
Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
|
Up to 6 weeks
|
Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3
Time Frame: Up to 6 weeks
|
Median change from baseline to post intervention.
Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
|
Up to 6 weeks
|
Biomarkers of Disease Progression - IGF-1
Time Frame: Up to 6 weeks
|
Median change from baseline to post intervention.
Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
|
Up to 6 weeks
|
Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)
Time Frame: Up to 6 weeks
|
Median change from baseline to post intervention.
Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
|
Up to 6 weeks
|
Biomarkers of Disease Progression - Total Testosterone
Time Frame: Up to 6 weeks
|
Median change from baseline to post intervention.
Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).
|
Up to 6 weeks
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-15835
- IRB 107980 (Other Identifier: USF IRB)
- 1P20MD003375-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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