Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy.
Baseline, 3, 6, 9 and 12 months
Charles J. Rosser, MD
University of Florida
United States: Institutional Review Board
|University of Florida Shands||Jacksonville, Florida 32209|