Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
NCT00596895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2011-09-20
Summary
Primary Outcome Measures:
Decrease in rate of serum PSA rise
Secondary Outcome Measures:
Adherence to treatment regimens
Quality of life as assessed by FACT-P at baseline and at 12 months of treatment
Modulation of serum testosterone,isoflavone metabolites, and cholesterol
Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Conditions
- Biochemical Recurrent Prostate Cancer
Interventions
- DIETARY_SUPPLEMENT
-
Isoflavone
Ingested 47 mg of isoflavone in three 8 oz servings per day
Sponsors & Collaborators
-
University of Florida
lead OTHER
Principal Investigators
-
Charles J. Rosser, MD · University of Florida
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-11-30
- Primary Completion
- 2007-11-30
- Completion
- 2007-11-30
Countries
- United States
Study Locations
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