Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Correlation of pretreatment ER-β expression with response to soy supplementation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
Intervention: soy isoflavones (Dietary Supplement)
Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
Intervention: soy protein isolate (Dietary Supplement)
Arm II
Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Correlation of pretreatment ER-β expression with response to soy supplementation
Time Frame: within 21 days after completetion of supplement regimen
after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.
Secondary Outcomes
No secondary outcomes reported