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)
- 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
- 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.
- 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.
- Metastatic or locally recurrent disease demonstrated on bone scan, computed
tomography or transrectal ultrasound, or be clinically symptomatic at the time of
- No androgen deprivation therapy (ADT) or chemotherapy within 12 months of entry into
- Known allergic reaction to milk or soy products were excluded.