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

NCT04403568 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: HSC20190735H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Radical Prostatectomy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Half-life

  The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.

  Baseline to 8 weeks

Secondary Outcomes (2)

• Levels of UA, CURC, and metabolites in prostate tissue

  Baseline to 8 weeks

• Immunohistochemistry measurement

  Baseline to 8 weeks

Study Arms (3)

Ursolic Acid

EXPERIMENTAL

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

Drug: Ursolic Acid

Curcumin

EXPERIMENTAL

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

Drug: Curcumin

Ursolic Acid and Curcumin

EXPERIMENTAL

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

Drug: Ursolic Acid; Drug: Curcumin

Interventions

Ursolic Acid DRUG

Ursolic Acid 150mg

Ursolic Acid; Ursolic Acid and Curcumin

Curcumin DRUG

Curcumin 600mg

Curcumin; Ursolic Acid and Curcumin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent
• Age \< 18
• High-risk prostate cancer or suspected metastasis
• Unable to swallow pills
• Unable to stop supplements

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ursolic Acid; Curcumin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Sapogenins; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Michael A Liss, MD

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified individual participant data will be available upon completion of the study for approx. 1 year.
• Access Criteria: Access granted upon request.

Locations

US (1)