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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04403568
• Other study ID #: HSC20190735H
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: October 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Mays Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, frequency, duration, and relation of toxicity events	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
Primary	Peak serum concentration	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
Primary	Time to reach peak serum concentration	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
Primary	Half-life	The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.	Baseline to 8 weeks
Secondary	Levels of UA, CURC, and metabolites in prostate tissue	Identify the presence and levels of UA, CURC and their metabolites in prostate tissue using HPLC.	Baseline to 8 weeks
Secondary	Immunohistochemistry measurement	Immunohistochemistry of proportion of nuclear p65 NFkB staining before and after prostatectomy on FFPE samples will be completed.	Baseline to 8 weeks