The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

Silibinin has demonstrated anti-cancer activity in the laboratory for several different cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle. Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer patients to determine the safety of high-dose treatment. This study is for men with prostate cancer who are planning to have their prostate surgically removed. Participants will be given Silybin-Phytosome three times a day from enrollment in the study until the time of their surgery. Participation in this study will not affect the timing of surgery. We obtain blood and urine samples at the start and completion of the trial in addition to prostate tissue from the surgery. These samples will be analyzed for the effect of Silybin-Phytosome at the end of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Sir Mortimer B. Davis - Jewish General Hospital
• Treatments: Silybin; Silymarin

Criteria

Inclusion Criteria:

1. Patients must sign an Institutional Review Board (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. Eastern Cooperative Oncology Group (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.