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

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ClinicalTrials.gov Identifier: NCT00487721
Recruitment Status : Completed
First Posted : June 19, 2007
Results First Posted : February 28, 2014
Last Update Posted : March 31, 2014
Sponsor:
Collaborator:
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Prostate Cancer
Intervention Drug: Silibin-Phytosome
Enrollment 12
Recruitment Details Twelve patients were recruited from the urologic oncology clinic at the University of Colorado Hospital between October of 2006 and October of 2007.
Pre-assignment Details All patients were newly diagnosed with prostate cancer and planning to pursue surgical radical prostatectomy. Patients were excluded from participation if they had received previous treatment for prostate cancer or if their surgery was scheduled within 14 days.
Arm/Group Title Silibin-Phytosome Control
Hide Arm/Group Description Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses. Subjects in the control arm did not receive any treatment or placebo.
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Silibin-Phytosome Control Total
Hide Arm/Group Description Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses. Subjects in the control arm did not receive any treatment or placebo. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
Since this was a pilot study, the number of patients was selected based on the feasibility of accrual and support, rather than statistical calculations. The results of this study will be considered in the planning of future trials with silibinin.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
4
  66.7%
9
  75.0%
>=65 years
1
  16.7%
2
  33.3%
3
  25.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
56.5
(46 to 66)
57.5
(49 to 65)
57
(46 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
12
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
12
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
6
 100.0%
12
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Measurable Silibinin Tissue Levels
Hide Description To determine if measurable silibinin tissue levels are detectable in the prostate glands of men treated with Silybin-Phytosome administered according to the protocol. Analysis of silibinin in human fluid and tissue samples was carried out by Liquid chromatography - mass spectrometric (LC/MS/MS) following liquid extraction. Briefly, sample was extracted in acidified ethyl acetate by vortex. Following centrifugation, the organic layer was evaporated to dryness in a rotary evaporator and the samples were dissolved in acetonitrile/ammonium acetate with acetic acid for analysis. Sample analysis was done using an Applied Biosystems 3200 Q-Trap 1 triple quadrupole mass spectrometer with an Agilent 1100 Liquid Chromatography system and HTC-PAL Leap Autosampler. Quantitation of silibinin in samples was done by internal standard reference and batch analysis verified by the inclusion of spiked quality control samples in the appropriate matrix.
Time Frame At the time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis was used and 6 participants that were enrolled in the study were included in the analysis.
Arm/Group Title Silibin-Phytosome
Hide Arm/Group Description:
Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
3
Time Frame Adverse events were assessed within 7 days of the end of of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silibin-Phytosome Control
Hide Arm/Group Description Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses. Subjects in the control arm did not receive any treatment or placebo.
All-Cause Mortality
Silibin-Phytosome Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Silibin-Phytosome Control
Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   0/6 (0.00%) 
General disorders     
Hospitalization or Prolonged Hospitalization  1  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Silibin-Phytosome Control
Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   0/6 (0.00%) 
Gastrointestinal disorders     
Diarrhea  1  3/6 (50.00%)  0/6 (0.00%) 
Investigations     
Hyperbilirubinemia  1  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Some end of study blood samples were not obtained due to the timing of surgery, tissue was successfully obtained in all participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Flaig
Organization: University of Colorado, Denver
Phone: (720) 848 0655
EMail: Thomas.Flaig@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00487721    
Other Study ID Numbers: 05-1076.cc
First Submitted: June 16, 2007
First Posted: June 19, 2007
Results First Submitted: January 15, 2014
Results First Posted: February 28, 2014
Last Update Posted: March 31, 2014