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

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ClinicalTrials.gov Identifier: NCT04403568
Recruitment Status : Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ursolic Acid Drug: Curcumin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403568


Contacts
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Contact: Michael A Liss, MD 210-567-5676 liss@uthscsa.edu
Contact: Allison Wheeler 210-450-8688 WheelerA2@uthscsa.edu

Locations
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United States, Texas
Mays Cancer Center
San Antonio, Texas, United States, 78229
Contact: Michael Liss, MD    210-567-5676    Liss@uthscsa.edu   
Contact: Allison Wheeler    210-567-1172    wheelera2@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Michael A Liss, MD University of Texas Health at San Antonio
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04403568    
Other Study ID Numbers: HSC20190735H
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be available upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: De-identified individual participant data will be available upon completion of the study for approx. 1 year.
Access Criteria: Access granted upon request.

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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
Keywords provided by The University of Texas Health Science Center at San Antonio:
Radical Prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Ursolic acid
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Cyclooxygenase Inhibitors