NCT04403568

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

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ursolic Acid	Ursolic Acid 150mg
DRUG	Curcumin	Curcumin 600mg

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-05-27
• Last updated: 2021-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study