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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Correlation of pretreatment ER-β expression with response to soy supplementation

Outcome Description:

after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.

Outcome Time Frame:

within 21 days after completetion of supplement regimen

Safety Issue:

No

Principal Investigator

M. Craig Hall, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000466317

NCT ID:

NCT00345813

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096