Know Cancer

or
forgot password

A Pilot Biomarker Study of Oral Silybin-Phytosome Followed by Prostatectomy in Patients With Localized Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Localized Prostate Cancer

Thank you

Trial Information

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Principal Investigator

L. Michael Glode, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

COMIRB Protocol 05-1076

NCT ID:

NCT00487721

Start Date:

September 2006

Completion Date:

December 2008

Related Keywords:

  • Localized Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Colorado HospitalDenver, Colorado  80262