Status:
COMPLETED
Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Soy protein may help prevent prostate cancer recurrence in patients who have undergone surgery for prostate cancer. PURPOSE: This randomized phase II/III trial is studying how well soy pro...
Detailed Description
OBJECTIVES: * Determine whether soy protein isolate reduces the PSA failure rate and time to PSA failure within 2 years following radical prostatectomy in patients who are at high risk for prostate c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT00765479
Start Date
December 1 2006
End Date
July 1 2013
Last Update
September 20 2013
Active Locations (1)
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1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243