Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments soy isoflavones, soy protein isolate, placebo
Phase phase 2
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date October 2003
End date July 2006
Trial size 62 participants
Trial identifier NCT00345813, CCCWFU-98203, CCCWFU-BG03-332, CDR0000466317

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
soy isoflavones
Given orally
soy protein isolate
Given orally
(Placebo Comparator)
Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.
placebo
Given orally

Primary Outcomes

Measure
Correlation of pretreatment ER-β expression with response to soy supplementation
time frame: within 21 days after completetion of supplement regimen

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.