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The Effect of High-Dose Silybin-Phytosome in Men With Prostate Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Active

Over 18

Other

COMIRB Protocol 05-1076
NCT00487721

Trial Description

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Colorado Cancer Center at UC Health Sciences Center

Jewish General Hospital - Montreal

L. Michael Glode, M.D.

Principal Investigator

Kathryn Breaker, R.N.		Ph: 720-848-0651
		Email: Kathryn.Breaker@uchsc.edu

Thomas Flaig, M.D.		Ph: 720-848-0170
		Email: Thomas.Flaig@uchsc.edu

Trial Sites

U.S.A.

Colorado

Aurora

University of Colorado Cancer Center at UC Health Sciences Center

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00487721
Information obtained from ClinicalTrials.gov on August 05, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.