Clinical trial NCT00345813: Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
Official title: Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-06-29
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Correlation of pretreatment ER-β expression with response to soy supplementation
timeFrame: within 21 days after completetion of supplement regimen
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: M. Craig Hall, MD
role: STUDY_CHAIR
References: