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

This study has been completed.
Sponsor:
Collaborator:
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00487721
First received: June 16, 2007
Last updated: December 1, 2008
Last verified: December 2008
History of Changes

June 16, 2007
December 1, 2008
September 2006
September 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00487721 on ClinicalTrials.gov Archive Site
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The Effect of High-Dose Silybin-Phytosome in Men With Prostate Cancer
A Pilot Biomarker Study of Oral Silybin-Phytosome Followed by Prostatectomy in Patients With Localized Prostate Cancer

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Localized Prostate Cancer
Drug: Silybin-Phytosome
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2008
September 2007   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00487721
COMIRB Protocol 05-1076
No
Not Provided
University of Colorado, Denver
Sir Mortimer B. Davis - Jewish General Hospital
Principal Investigator: L. Michael Glode, M.D. University of Colorado, Denver
University of Colorado, Denver
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP