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

The University of Texas System (UT)

Status and phase: Withdrawn; Early Phase 1

Conditions: Prostate Cancer

Treatments: Drug: Ursolic Acid; Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT04403568

HSC20190735H

Details and patient eligibility

About

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

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Ursolic Acid

Experimental group

Description:

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

Treatment:

Drug: Ursolic Acid

Curcumin

Experimental group

Description:

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

Treatment:

Drug: Curcumin

Ursolic Acid and Curcumin

Experimental group

Description:

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

Treatment:

Drug: Curcumin

Drug: Ursolic Acid