Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate

Overview

A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect

Full Title of Study: “Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Detailed Description

Once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (SOC) appointment or via telephone. Patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. Following informed consent, subjects will be assigned to one of the following cohorts:

Cohort 1:

• Ursolic Acid (150 mg) BID (twice a day)

Cohort 2:

• Curcumin (600 mg) BID

Cohort 3:

• Ursolic Acid (150 mg) and Curcumin (600 mg) BID

The study team aim to enroll 10 subjects who will complete the study into each cohort for a total of 30 completers. Subjects will be enrolled on a rolling basis with the first ten subjects assigned to Cohort 1, the next ten subjects assigned to Cohort 2, and the last 10 subjects assigned to Cohort 3.

Interventions

  • Drug: Ursolic Acid
    • Ursolic Acid 150mg
  • Drug: Curcumin
    • Curcumin 600mg

Arms, Groups and Cohorts

  • Experimental: Ursolic Acid
    • Administration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy
  • Experimental: Curcumin
    • Administration of Curcumin to subjects who are scheduled to undergo radical prostatectomy
  • Experimental: Ursolic Acid and Curcumin
    • Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy

Clinical Trial Outcome Measures

Primary Measures

  • Number, frequency, duration, and relation of toxicity events
    • Time Frame: Baseline to 8 weeks
    • Safety will be compared to evaluate the number, frequency, duration, and relation of toxicity events to CURC/UA combination, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.
  • Peak serum concentration
    • Time Frame: Baseline to 8 weeks
    • Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.
  • Time to reach peak serum concentration
    • Time Frame: Baseline to 8 weeks
    • The pharmacokinetic parameter, the area under the curve (Tmax) representing the time it takes to reach Cmax of ursolic acid, curcumin, and their metabolites will be graphed.
  • Half-life
    • Time Frame: Baseline to 8 weeks
    • The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.

Secondary Measures

  • Levels of UA, CURC, and metabolites in prostate tissue
    • Time Frame: Baseline to 8 weeks
    • Identify the presence and levels of UA, CURC and their metabolites in prostate tissue using HPLC.
  • Immunohistochemistry measurement
    • Time Frame: Baseline to 8 weeks
    • Immunohistochemistry of proportion of nuclear p65 NFkB staining before and after prostatectomy on FFPE samples will be completed.

Participating in This Clinical Trial

Inclusion Criteria

  • Have proven diagnosis of prostate cancer with Gleason Group 3 or lower and planning to undergo radical prostatectomy
  • Be able to give informed consent
  • Be age 18 or older
  • Able to stop supplements

Exclusion Criteria

  • Unable to give informed consent
  • Age < 18
  • High-risk prostate cancer or suspected metastasis
  • Unable to swallow pills
  • Unable to stop supplements

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center at San Antonio
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael A Liss, MD, Principal Investigator, University of Texas Health at San Antonio
  • Overall Contact(s)
    • Michael A Liss, MD, 210-567-5676, liss@uthscsa.edu

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