Prostate Cancer Clinical Trial
Official title:
A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary
for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with
localized prostate cancer who are planning to undergo radical prostatectomy.
OBJECTIVES:
- Determine the toxicity of genistein in patients with localized prostate cancer treated
with radical prostatectomy.
- Determine the decrease, if any, of prostate-specific antigen-positive cells in the
operative field of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients receive 1 of 2 treatment regimens.
- Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical
prostatectomy, and then continue oral genistein once daily for 1-2 months afterward
(for a total of 3 months of therapy).
- Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery,
patients receive genistein as in arm I for 3 months.
Quality of life is assessed at baseline and at 1 and 3 months after surgery.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued
for this study within 2 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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