Clinical Trials /

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

NCT04403568

Description:

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT04403568

Trial Eligibility

Document

Title

  • Brief Title: Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
  • Official Title: Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate

Clinical Trial IDs

  • ORG STUDY ID: HSC20190735H
  • NCT ID: NCT04403568

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Ursolic AcidUrsolic Acid
CurcuminCurcumin

Purpose

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

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.

Trial Arms

NameTypeDescriptionInterventions
Ursolic AcidExperimentalAdministration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy
  • Ursolic Acid
CurcuminExperimentalAdministration of Curcumin to subjects who are scheduled to undergo radical prostatectomy
  • Curcumin
Ursolic Acid and CurcuminExperimentalAdministration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy
  • Ursolic Acid
  • Curcumin

Eligibility Criteria

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number, frequency, duration, and relation of toxicity events
Time Frame:Baseline to 8 weeks
Safety Issue:
Description: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.

Secondary Outcome Measures

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

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:The University of Texas Health Science Center at San Antonio

Trial Keywords

  • Radical Prostatectomy

Last Updated

June 23, 2021