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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04403568

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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 3Subjects 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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number, frequency, duration, and relation of toxicity events [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 [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 [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 [Baseline to 8 weeks]
The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mays Cancer Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

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:

Prostatic Neoplasms

Ursolic acid

Curcumin

Study Results

No Results Posted as of Sep 16, 2021