This phase I trial investigates the side effects of curcumin and ursolic acid, as well as their rate of absorption in the blood (bioavailability), their absorption in the prostate, and their interactions and effect within the body in patients with prostate cancer. Dietary supplements, such as curcumin and ursolic acid, may slow the growth of prostate cancer. This trial may help researchers learn if a combination of curcumin and ursolic acid has greater combined (synergistic) absorption in the body, which may lead to future clinical trials and ultimately to a safe and effective treatment in patients diagnosed with prostate cancer to reduce the progression of disease.
Additional locations may be listed on ClinicalTrials.gov for NCT04403568.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Evaluate the bioavailability and safety of curcumin, ursolic acid, and their combination in a phase 1 clinical trial using a pharmacokinetic approach.
II. Determine levels of ursolic acid (UA), curcumin (CURC), and metabolites within the prostate as the target organ.
III. To identify NFkappaB/Stat3 as the target biologic signature associated with the combinatorial activity of phytonutrients in prostate tissue.
OUTLINE: Patients are randomized to 1 of 3 cohorts.
COHORT 1: Patients receive ursolic acid orally (PO) twice daily (BID) for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care prostatectomy.
COHORT 2: Patients receive curcumin PO BID for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care prostatectomy.
COHORT 3: Patients receive ursolic acid PO BID and curcumin PO BID for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care prostatectomy.
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorMichael A. Liss
