Clinical trial NCT04403568: Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
Official title: Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Keywords: Radical Prostatectomy
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Number, frequency, duration, and relation of toxicity events
timeFrame: Baseline to 8 weeks
measure: Peak serum concentration
timeFrame: Baseline to 8 weeks
measure: Time to reach peak serum concentration
timeFrame: Baseline to 8 weeks
measure: Half-life
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Levels of UA, CURC, and metabolites in prostate tissue
timeFrame: Baseline to 8 weeks
measure: Immunohistochemistry measurement
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Mays Cancer Center
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Michael A Liss, MD
role: PRINCIPAL_INVESTIGATOR
References: