Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00765479
- Lead Sponsor
- University of Illinois at Chicago
- 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 protein works and compares it to a placebo in preventing recurrent cancer in patients who have undergone surgery for stage II prostate cancer.
- 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 cancer recurrence.
* Determine the effects of soy protein isolate on intermediate biomarkers of steroid hormone axis (testosterone, estradiol, and SHBG) and thyroid activity (T3 and T4).
* Determine the effects of soy protein isolate on intermediate biomarkers of apoptosis (soluble Fas and Fas-ligand), angiogenesis (VEGF and bFGF), antioxidant activity (8-isoprostanes), and IGF axis (IGF-1 and IGFBP-3).
* Compare patients who are equol producers to those who are non-producers.
OUTLINE: This is a multicenter study. Patients are stratified according to hospital/clinic site (NYU vs UIC or Jesse Brown VA Medical Center vs other sites), number of high-risk characteristics (1 vs \> 1), and race (African American vs non-African American \[i.e., non-Hispanic White, Hispanic, Asian, and other\]). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive an oral soy protein isolate beverage once daily.
* Arm II: Patients receive an oral casein placebo beverage once daily. Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for biomarker laboratory studies. Samples are analyzed to measure PSA levels by Tosoh PSA assay; cholesterol levels; isoflavone and equol concentrations by HPLC and ESA; and indicators of steroid hormone axis (testosterone, estradiol, and SHBG), indicators of thyroid activity (T3 and T4), indicators of apoptosis (soluble Fas and Fas-ligand), indicators of angiogenesis (VEGF and bFGF), indicators of oxidative stress (8-isoprostanes), and indicators of IGF axis (IGF-1 and IGFBP-3) by ELISA.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 284
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to PSA failure Two-year PSA failure rate (as surrogate for recurrence)
- Secondary Outcome Measures
Name Time Method Serum total cholesterol levels Apoptotic activity as measured by serum soluble Fas and Fas-ligand levels Oxidative stress as measured by serum 8-isoprostane levels Equol production as measured by serum equol concentration Angiogenesis as measured by serum VEGF and bFGF levels Steroid hormone axis as measured by serum testosterone, estradiol, and SHBG levels Thyroid activity as measured by serum T3 and T4 levels Isoflavone uptake or compliance as measured by serum isoflavone concentration IGF axis as measured by serum IGF-1 and IGFBP-3 levels
Trial Locations
- Locations (1)
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
University of Illinois Cancer Center🇺🇸Chicago, Illinois, United States