Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer
NCT ID: NCT00765479
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
284 participants
INTERVENTIONAL
2006-12-31
2013-07-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Study Groups
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Arm I
Patients receive an oral soy protein isolate beverage once daily.
soy protein isolate
Given orally
Arm II
Patients receive an oral casein placebo beverage once daily.
placebo
Given orally
Interventions
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soy protein isolate
Given orally
placebo
Given orally
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
75 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Illinois at Chicago
OTHER
Principal Investigators
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Maarten C. Bosland, DVSc, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Roohollah Sharifi, MD
Role:
University of Illinois at Chicago
Locations
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University of Illinois Cancer Center
Chicago, Illinois, United States
Countries
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References
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Bosland MC, Enk E, Schmoll J, Schlicht MJ, Randolph C, Deaton RJ, Xie H, Zeleniuch-Jacquotte A, Kato I. Soy protein supplementation in men following radical prostatectomy: a 2-year randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2021 Apr 6;113(4):821-831. doi: 10.1093/ajcn/nqaa390.
Bosland MC, Huang J, Schlicht MJ, Enk E, Xie H, Kato I. Impact of 18-Month Soy Protein Supplementation on Steroid Hormones and Serum Biomarkers of Angiogenesis, Apoptosis, and the Growth Hormone/IGF-1 Axis: Results of a Randomized, Placebo-Controlled Trial in Males Following Prostatectomy. Nutr Cancer. 2022;74(1):110-121. doi: 10.1080/01635581.2020.1870706. Epub 2021 Jan 12.
Bosland MC, Kato I, Zeleniuch-Jacquotte A, Schmoll J, Enk Rueter E, Melamed J, Kong MX, Macias V, Kajdacsy-Balla A, Lumey LH, Xie H, Gao W, Walden P, Lepor H, Taneja SS, Randolph C, Schlicht MJ, Meserve-Watanabe H, Deaton RJ, Davies JA. Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy: a randomized trial. JAMA. 2013 Jul 10;310(2):170-8. doi: 10.1001/jama.2013.7842.
Other Identifiers
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UIC-2006-0706
Identifier Type: -
Identifier Source: secondary_id
CDR0000615902
Identifier Type: -
Identifier Source: org_study_id