Expired Study
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Jacksonville, Florida 32209


Purpose:

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)


Study summary:

- Pretreatment evaluation included a complete medical history, physical examination (including digital rectal examination), serum PSA, free/total testosterone, lipids, serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of life (Functional Assessment of Cancer Treatment-Prostate, FACT-P questionnaire). - Whole blood will be obtained prior to initiation of the study to assess for DNA polymorphism. - Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment. - Medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.


Criteria:

Inclusion Criteria: - Raising serum PSA profile after previous definitive therapy (e.g., radical prostatectomy or external beam radiation therapy). - Life expectancy of at least one year and performance status of <2 of Zubrod scale. Exclusion Criteria: - Metastatic or locally recurrent disease demonstrated on bone scan, computed tomography or transrectal ultrasound, or be clinically symptomatic at the time of enrollment - No androgen deprivation therapy (ADT) or chemotherapy within 12 months of entry into the study. - Known allergic reaction to milk or soy products were excluded.


NCT ID:

NCT00596895


Primary Contact:

Principal Investigator
Charles J. Rosser, MD
University of Florida


Backup Contact:

N/A


Location Contact:

Jacksonville, Florida 32209
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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