Status:
COMPLETED
Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
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 ...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00345813
Start Date
October 1 2003
End Date
July 1 2006
Last Update
August 10 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096