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Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00345813
Enrollment
62
Registered
2006-06-29
Start date
2003-10-31
Completion date
2006-07-31
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Brief summary

RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery. PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.

Detailed description

OBJECTIVES: Primary * Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy. Secondary * Compare the toxicity and side effects of these regimens in these patients. * Compare the dietary patterns of these patients. OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral soy supplementation daily for 4 weeks. * Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation. Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.

Interventions

DIETARY_SUPPLEMENTsoy isoflavones

Given orally

DIETARY_SUPPLEMENTsoy protein isolate

Given orally

OTHERplacebo

Given orally

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Clinically localized disease * Scheduled for radical prostatectomy * No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * No evidence of active nephrolithiasis * No history of hypercalcemic syndrome PRIOR CONCURRENT THERAPY: * No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs * No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil

Design outcomes

Primary

MeasureTime frameDescription
Correlation of pretreatment ER-β expression with response to soy supplementationwithin 21 days after completetion of supplement regimenafter a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026