NCT04403568WITHDRAWNEARLY_Phase 1

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

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

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

—

Sites

1 locations

Start Date

October 2021

Completion

December 2022

Prostate CancerUrsolic AcidCurcumin

View on ClinicalTrials.gov

Primary Outcomes

Number, frequency, duration, and relation of toxicity events

Baseline to 8 weeks

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.

Peak serum concentration

Baseline to 8 weeks

Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.

Time to reach peak serum concentration

Baseline to 8 weeks

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.

Half-life

Baseline to 8 weeks

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

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Fetching protocol from ClinicalTrials.gov…

NCT04403568WITHDRAWNEARLY_Phase 1

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

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

—

Sites

1 locations

Start Date

October 2021

Completion

December 2022

Prostate CancerUrsolic AcidCurcumin

View on ClinicalTrials.gov

Primary Outcomes

Number, frequency, duration, and relation of toxicity events

Baseline to 8 weeks

Peak serum concentration

Baseline to 8 weeks

Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.

Time to reach peak serum concentration

Baseline to 8 weeks

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.

Half-life

Baseline to 8 weeks

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

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

View full 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

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

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Trial Sites (1)