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

September 8, 2021 updated by: The University of Texas Health Science Center at San Antonio

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Mays Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ursolic Acid
Administration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy
Drug: Ursolic Acid
Ursolic Acid 150mg
Experimental: Curcumin
Administration of Curcumin to subjects who are scheduled to undergo radical prostatectomy
Drug: Curcumin
Curcumin 600mg
Experimental: Ursolic Acid and Curcumin
Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy
Drug: Ursolic Acid
Ursolic Acid 150mg
Drug: Curcumin
Curcumin 600mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
Half-life
Time Frame: Baseline to 8 weeks
The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Michael A Liss, MD, University of Texas Health at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20190735H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data will be available upon request.

IPD Sharing Time Frame

De-identified individual participant data will be available upon completion of the study for approx. 1 year.

IPD Sharing Access Criteria

Access granted upon request.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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