Prostate Cancer
Conditions
Keywords
Radical Prostatectomy
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
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.
Interventions
DRUGUrsolic Acid
Ursolic Acid 150mg
DRUGCurcumin
Curcumin 600mg
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of UA, CURC, and metabolites in prostate tissue | Baseline to 8 weeks | Identify the presence and levels of UA, CURC and their metabolites in prostate tissue using HPLC. |
| Immunohistochemistry measurement | Baseline to 8 weeks | Immunohistochemistry of proportion of nuclear p65 NFkB staining before and after prostatectomy on FFPE samples will be completed. |
Countries
United States
Outcome results
None listed