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

NCT ID: NCT04403568

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2023-12-31

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

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ursolic Acid

Administration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy

Group Type: EXPERIMENTAL

Ursolic Acid

Intervention Type: DRUG

Ursolic Acid 150mg

Curcumin

Administration of Curcumin to subjects who are scheduled to undergo radical prostatectomy

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Curcumin 600mg

Ursolic Acid and Curcumin

Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy

Group Type: EXPERIMENTAL

Ursolic Acid

Intervention Type: DRUG

Ursolic Acid 150mg

Curcumin

Intervention Type: DRUG

Curcumin 600mg

Interventions

Ursolic Acid

Ursolic Acid 150mg

Intervention Type: DRUG

Curcumin

Curcumin 600mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Liss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health at San Antonio

Locations

Mays Cancer Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20190735H

Identifier Type: -

Identifier Source: org_study_id