A Pilot Biomarker Study of Oral Silybin-Phytosome Followed by Prostatectomy in Patients With Localized Prostate Cancer
Inclusion Criteria:
1. Patients must sign an IRB-approved informed consent
2. Age greater than 18 years old
3. Male patients with histologically documented adenocarcinoma of the prostate
4. Life expectancy greater than three months
5. ECOG performance status ≤ 2
6. Adequate organ function including a total Bilirubin less than or equal to 1.5 mg/dl
7. Planned prostatectomy as treatment for prostate cancer.
8. No known metastatic disease
Exclusion Criteria:
1. Prior definitive treatment for prostate cancer with surgery or radiation therapy
2. Use of an investigational medication or device within one month of initiating study
therapy.
3. Prior systemic chemotherapy for prostate cancer or any hormonal therapy for prostate
cancer.
4. Any use of hormonal therapy (i.e. luteinizing hormone-releasing hormone analog) or
anti-androgen therapy.
5. Any condition or any medication which may interfere with the conduct of the study as
determined by the principal investigator.