Randomized Placebo-Controlled Adjuvant Study of Prevention of Prostate Cancer Recurrence After Radical Prostatectomy by Soy Protein Isolate
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Arm I
Experimental
Patients receive an oral soy protein isolate beverage once daily.
Arm II
Placebo Comparator
Patients receive an oral casein placebo beverage once daily.
Intervention(s)
placebo, soy protein isolate,
Patient eligibility
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer
- Clinically localized (T1c or T2) disease
- At high risk for recurrence, as defined by >= 1 of the following:
- Preoperative PSA > 20.0 ng/mL
- Seminal vesicle invasion
- Extracapsular extension (excluding the bladder neck)
- Positive surgical margins (excluding apical margins)
- Micrometastases in any removed pelvic lymph nodes
- Final Gleason score of >= 8
- Must have undergone radical prostatectomy for prostate cancer within the past 4
months
- Must have an undetectable PSA (< 0.07 ng/mL) at baseline, as measured by Tosoh PSA
assay
- No clinical evidence of locally recurrent or metastatic disease
PATIENT CHARACTERISTICS:
- No significant intake of soy (i.e., more than once a week) at baseline including, but
not limited to, any of the following:
- Vegetarians who regularly consume soy products (e.g., tofu)
- Individuals with customary Asian dietary habits, including regular intake of soy
products
- Individuals who use soy-based milk replacements
- No anemia, iron deficiency problems, or subclinical iron deficiency at baseline
- No diabetes
- No thyroid disease
- No requirement for a sodium-free diet
- No substantive tendency to be constipated (i.e., >= grade 2 constipation experienced
regularly)
- No medical problem that would preclude the consumption of the soy containing beverage
powder, including allergies against soy (or milk protein)
- No concurrent major disease, including major mental disease or major substance abuse
problems
- No significant side effects from medication
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent radiotherapy or hormonal therapy
- No other concurrent adjuvant therapy for prostate cancer
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
