Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer

NCT00765479 | Completed Phase 2

• 2 other identifiers: CDR0000615902UIC-2006-0706
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (2)

• Two-year PSA failure rate (as surrogate for recurrence)

• Time to PSA failure

Secondary Outcomes (9)

• Isoflavone uptake or compliance as measured by serum isoflavone concentration

• Serum total cholesterol levels

• Steroid hormone axis as measured by serum testosterone, estradiol, and SHBG levels

• Thyroid activity as measured by serum T3 and T4 levels

• Apoptotic activity as measured by serum soluble Fas and Fas-ligand levels

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive an oral soy protein isolate beverage once daily.

Dietary Supplement: soy protein isolate

Arm II

PLACEBO COMPARATOR

Patients receive an oral casein placebo beverage once daily.

Other: placebo

Interventions

soy protein isolate DIETARY_SUPPLEMENT

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Related Publications (3)

• 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.

  PMID: 33564828 DERIVED

• 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.

  PMID: 33432829 DERIVED

• 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.

  PMID: 23839751 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Maarten C. Bosland, DVSc, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Roohollah Sharifi, MD

  University of Illinois at Chicago

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: December 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2013
• Last Updated: September 20, 2013

Record last verified: 2009-08

Locations

US (1)