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

NCT ID: NCT01036321

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-11
• Study Completion Date: 2018-04-16

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Purified Isoflavones

Soy-based isoflavone concentrate with methyl cellulose blend filler. 40 mg daily.

Group Type: ACTIVE_COMPARATOR

Purified isoflavones

Intervention Type: DRUG

Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily

Methyl cellulose blend

Placebo.

Group Type: PLACEBO_COMPARATOR

Methyl cellulose blend

Intervention Type: DRUG

Placebo - Take 2 capsules daily

Interventions

Purified isoflavones

Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily

Intervention Type: DRUG

Methyl cellulose blend

Placebo - Take 2 capsules daily

Intervention Type: DRUG

Other Intervention Names

Novasoy 400; Avicel PH105; Avicel PH105

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nagi Kumar, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

University of Florida & Shands Medical Center - Jacksonville

Jacksonville, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

James A. Haley VA Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

IRB 107980

Identifier Type: OTHER

Identifier Source: secondary_id

1P20MD003375-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-15835

Identifier Type: -

Identifier Source: org_study_id