Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Silibin-Phytosome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Silibin-Phytosome
- description
- Subjects in this group will take Silibin-Phytosome 13 grams daily, in three divided doses for 2-10 weeks.
- interventionNames
- Drug: Silibin-Phytosome
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients in this arm will not take any intervention.
Primary outcomes (1)
- measure
- Measurable Silibinin Tissue Levels
- timeFrame
- At the time of surgery
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must sign an Institutional Review Board (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. Eastern Cooperative Oncology Group (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.
References
Publications (2)
- BACKGROUNDFlaig TW, Gustafson DL, Su LJ, Zirrolli JA, Crighton F, Harrison GS, Pierson AS, Agarwal R, Glode LM. A phase I and pharmacokinetic study of silybin-phytosome in prostate cancer patients. Invest New Drugs. 2007 Apr;25(2):139-46. doi: 10.1007/s10637-006-9019-2. Epub 2006 Nov 1. PMID 17077998
- DERIVEDFlaig TW, Glode M, Gustafson D, van Bokhoven A, Tao Y, Wilson S, Su LJ, Li Y, Harrison G, Agarwal R, Crawford ED, Lucia MS, Pollak M. A study of high-dose oral silybin-phytosome followed by prostatectomy in patients with localized prostate cancer. Prostate. 2010 Jun 1;70(8):848-55. doi: 10.1002/pros.21118. PMID 20127732