NCT00617617

Brief Summary

The purpose of this research study is to determine if giving men with early stage (Grade 1-2) prostate cancer dietary supplement from soybeans called isoflavones, will change their blood hormone levels. Isoflavones are substances found in a high concentration in soybeans that are converted in the intestines to hormone-like compounds which are similar to estrogen. They are also thought to have cancer fighting properties. Clinical trials suggest that isoflavones can increase certain sex hormones, which results in the slower production of prostate cancer cells. This study will determine if adding isoflavones (supplied as Prevastein HC®) 80 mg/day in a pill form can change your risk factors that cause early stage prostate cancer to progress to more advanced disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2002

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
Last Updated

September 24, 2012

Status Verified

February 1, 2010

Enrollment Period

5.2 years

First QC Date

February 5, 2008

Last Update Submit

September 21, 2012

Conditions

Prostate Cancer

Keywords

isoflavonessoy

Outcome Measures

Primary Outcomes (1)

  • Observe the effects of the 12 - week intervention with isoflavones on sex hormones and PSA, a marker of disease progression.

    12 week treatments

Study Arms (2)

A

EXPERIMENTAL

Dietary Supplement: Prevastein HC®

Dietary Supplement: Prevastein HC®

B

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Prevastein HC®DIETARY_SUPPLEMENT

Experimental Group - Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones.

A
PlaceboOTHER

Control Group - Control Group participants will receive an identical placebo.

B

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males, between the ages of 50 and 80
  • Diagnosed with grade 1-2 prostate cancer (Gleason Score 2 to 6) Note: patients with a Gleason primary pattern 4 (4+1 or 4+2) are not eligible.
  • No prior or current therapy for prostate cancer
  • No other history of cancer except non-melanoma skin cancer
  • No known history of hepatic and/or renal disease
  • No evidence of prostatitis or urinary tract infection (men being treated with antibiotics may be enrolled 30 days after completion of therapy given that they still meet all other eligibility criteria)
  • No antibiotic use within 30 days of registration
  • Close to ideal body weight(Body Mass Index no greater than 32 Kg/m²)
  • Omnivorous diet
  • Able and willing to give written consent

You may not qualify if:

  • Less than 50 years or over 80 years of age
  • Prostate cancer beyond grade 2 (Gleason Score greater than 6)
  • Gleason primary pattern 4 (4+1 or 4+2)
  • Prior or planned treatment for prostate cancer of any stage
  • Prior history of other cancer except non-melanoma skin cancer
  • Current use of nutritional supplements, including modular supplements of other agents with antioxidant properties e.g. retinoids, beta-carotene, and isoflavones
  • Allergy to study agent
  • Known history of hepatic or renal disease
  • Body Mass Index greater than 32 Kg/m²
  • Vegetarian/vegan diet
  • Diet high in soy products (men who routinely consume a diet high in soy products may be enrolled 30 days after eliminating soy product from the diet)
  • Prostatitis or urinary tract infection
  • Treatment with antibiotics within 30 days of registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Nagi B. Kumar, PhD., RD

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 18, 2008

Study Start

February 1, 2002

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

September 24, 2012

Record last verified: 2010-02

Locations

US(1)