Trial Outcomes & Findings for The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer (NCT NCT00487721)
NCT ID: NCT00487721
Last Updated: 2014-03-31
Results Overview
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.
COMPLETED
PHASE2
12 participants
At the time of surgery
2014-03-31
Participant Flow
Twelve patients were recruited from the urologic oncology clinic at the University of Colorado Hospital between October of 2006 and October of 2007.
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.
Participant milestones
| Measure |
Silibin-Phytosome
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.
|
Control
Subjects in the control arm did not receive any treatment or placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Silibin-Phytosome
n=6 Participants
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.
|
Control
n=6 Participants
Subjects in the control arm did not receive any treatment or placebo.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
56.5 Years
n=5 Participants
|
57.5 Years
n=7 Participants
|
57 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of surgeryPopulation: Per protocol analysis was used and 6 participants that were enrolled in the study were included in the analysis.
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.
Outcome measures
| Measure |
Silibin-Phytosome
n=6 Participants
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.
|
|---|---|
|
Measurable Silibinin Tissue Levels
|
3 Participants
|
Adverse Events
Silibin-Phytosome
Control
Serious adverse events
| Measure |
Silibin-Phytosome
n=6 participants at risk
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.
|
Control
n=6 participants at risk
Subjects in the control arm did not receive any treatment or placebo.
|
|---|---|---|
|
General disorders
Hospitalization or Prolonged Hospitalization
|
16.7%
1/6 • Adverse events were assessed within 7 days of the end of of the study.
|
0.00%
0/6 • Adverse events were assessed within 7 days of the end of of the study.
|
Other adverse events
| Measure |
Silibin-Phytosome
n=6 participants at risk
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.
|
Control
n=6 participants at risk
Subjects in the control arm did not receive any treatment or placebo.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Adverse events were assessed within 7 days of the end of of the study.
|
0.00%
0/6 • Adverse events were assessed within 7 days of the end of of the study.
|
|
Investigations
Hyperbilirubinemia
|
16.7%
1/6 • Adverse events were assessed within 7 days of the end of of the study.
|
0.00%
0/6 • Adverse events were assessed within 7 days of the end of of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place