Clinical trial · Interventional
Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer
Randomized Placebo-Controlled Adjuvant Study of Prevention of Prostate Cancer Recurrence After Radical Prostatectomy by Soy Protein Isolate
NCT00765479CI-TRIAL-00012247completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| soy protein isolate | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive an oral soy protein isolate beverage once daily.
- interventionNames
- Dietary Supplement: soy protein isolate
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive an oral casein placebo beverage once daily.
- interventionNames
- Other: placebo
Primary outcomes (2)
- measure
- Two-year PSA failure rate (as surrogate for recurrence)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDBosland 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
- DERIVEDBosland 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
- DERIVEDBosland 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