The Effect of High-Dose Silybin-Phytosome in Men With Prostate Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Localized Prostate Cancer |
Drug: Silybin-Phytosome |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Pilot Biomarker Study of Oral Silybin-Phytosome Followed by Prostatectomy in Patients With Localized Prostate Cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
Inclusion Criteria:
- Patients must sign an IRB-approved informed consent
- Age greater than 18 years old
- Male patients with histologically documented adenocarcinoma of the prostate
- Life expectancy greater than three months
- ECOG performance status ≤ 2
- Adequate organ function including a total Bilirubin less than or equal to 1.5 mg/dl
- Planned prostatectomy as treatment for prostate cancer.
- No known metastatic disease
Exclusion Criteria:
- Prior definitive treatment for prostate cancer with surgery or radiation therapy
- Use of an investigational medication or device within one month of initiating study therapy.
- Prior systemic chemotherapy for prostate cancer or any hormonal therapy for prostate cancer.
- Any use of hormonal therapy (i.e. luteinizing hormone-releasing hormone analog) or anti-androgen therapy.
- Any condition or any medication which may interfere with the conduct of the study as determined by the principal investigator.
Contacts and Locations| United States, Colorado | |
| University of Colorado Hospital | |
| Aurora, Colorado, United States, 80010 | |
| Principal Investigator: | L. Michael Glode, M.D. | University of Colorado, Denver |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00487721 History of Changes |
| Other Study ID Numbers: | COMIRB Protocol 05-1076 |
| Study First Received: | June 16, 2007 |
| Last Updated: | December 1, 2008 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Silybin Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013