Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
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|ClinicalTrials.gov Identifier: NCT04403568|
Recruitment Status : Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Ursolic Acid Drug: Curcumin||Early Phase 1|
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:
• Ursolic Acid (150 mg) BID (twice a day)
• Curcumin (600 mg) BID
• 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Ursolic Acid
Administration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy
Drug: Ursolic Acid
Ursolic Acid 150mg
Administration of Curcumin to subjects who are scheduled to undergo radical prostatectomy
Experimental: Ursolic Acid and Curcumin
Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy
Drug: Ursolic Acid
Ursolic Acid 150mg
- Number, frequency, duration, and relation of toxicity events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to 8 weeks ]The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.
- Levels of UA, CURC, and metabolites in prostate tissue [ Time Frame: Baseline to 8 weeks ]Identify the presence and levels of UA, CURC and their metabolites in prostate tissue using HPLC.
- Immunohistochemistry measurement [ Time Frame: Baseline to 8 weeks ]Immunohistochemistry of proportion of nuclear p65 NFkB staining before and after prostatectomy on FFPE samples will be completed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403568
|Contact: Michael A Liss, MDfirstname.lastname@example.org|
|Contact: Allison Wheeler||210-450-8688||WheelerA2@uthscsa.edu|
|Principal Investigator:||Michael A Liss, MD||University of Texas Health at San Antonio|