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

NCT01036321 | Completed Phase 2 Results DMC

• 3 other identifiers: MCC-15835IRB 1079801P20MD003375-01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Median Change in Percent Ki-67 From Baseline

  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

  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 Outcomes (8)

• Biomarkers of Disease Progression - Serum PSA

  Up to 6 weeks

• Change in Plasma Concentrations of Isoflavone

  Up to 6 weeks

• Biomarkers of Disease Progression - Estradiol

  Up to 6 weeks

• Biomarkers of Disease Progression - Free Testosterone

  Up to 6 weeks

• Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3

  Up to 6 weeks

Study Arms (2)

Purified Isoflavones

ACTIVE COMPARATOR

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

Drug: Purified isoflavones

Methyl cellulose blend

PLACEBO COMPARATOR

Placebo.

Drug: Methyl cellulose blend

Interventions

Purified isoflavones DRUG

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

Also known as: Novasoy 400, Avicel PH105

Purified Isoflavones

Methyl cellulose blend DRUG

Placebo - Take 2 capsules daily

Also known as: Avicel PH105

Methyl cellulose blend

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

University of Florida & Shands Medical Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

James A. Haley VA Hospital

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Since the accrual of African American Men (AAM) was far lower than expected, this study was ultimately underpowered to detect small changes in specific biomarkers of disease progression proposed in men with localized prostate cancer (PCa).

Results Point of Contact

• Title: Nagi Kumar, Ph.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

nagi.kumar@moffitt.org

813-745-6885

Study Officials

• Nagi Kumar, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 11, 2009
• Primary Completion: June 26, 2014
• Study Completion: April 16, 2018
• Last Updated: August 6, 2019
• Results First Posted: August 13, 2015

Record last verified: 2019-08

Locations

US (3)