Biochemical Recurrent Prostate Cancer
Conditions
Keywords
Isoflavone, PSA, prostate cancer, recurrent, quality of life
Brief 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)
Detailed description
* 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.
Interventions
DIETARY_SUPPLEMENTIsoflavone
Ingested 47 mg of isoflavone in three 8 oz servings per day
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Assess the effect of soy protein/isoflavones on serum testosterone, isoflavone metabolites, and cholesterol. Assess the effect of soy protein/isoflavones on quality of life of these patients. | Baseline, 3, 6, 9 and 12 months |
Countries
United States
Outcome results
None listed