Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
Conditions
Prostate Cancer, Refractory Cancer, Castration Resistant Prostatic CancerDrugs
Omeprazole 80 mg twice dailySummary
The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. Investigators believe omeprazole may help the other medications work.
Detailed Description
Primary Objective(s): Obtain Overall Response Rate (ORR) to taxane therapy by adding the fatty acid synthase inhibitor, omeprazole to the current “failing” taxane regimen in 15% of subjects using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, defined by partial response (PR) or complete response (CR)
Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer Center main campus):
* Pharmacodynamics-demonstrate omeprazole in vivo fatty acid synthase inhibition by 11C-Acetate PET/CT (3-6) Non-invasive approach to demonstrate the fatty acid synthase inhibitor (omeprazole) is hitting its target
* Obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to the current “failing” taxane regimen. (16)
* Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS) at Baseline, Cycle 5, Cycle 12, and every cycle thereafter.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Study Coordinator
- [email protected]
Principal Investigator
- Michael Goodman, MD
Status
- RECRUITING
Contact Person
- Study Coordinator
- [email protected]
Principal Investigator
- Michael Goodman, MD
Eligibility Criteria
Inclusion Criteria:
* Patients must have castrate refractory prostate cancer with prior taxane treatment (docetaxel or cabazitaxel) which was used in the castrate refractory setting
* Cancer Progression as defined by PCWG3
* Age 18 or older.
* ECOG 0, 1, or 2
* Life expectancy of greater than 2 months
* Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
* Organ & marrow function as defined below: Absolute neutrophil count >1,200/mcL Platelets >75,000/mcL; total bilirubin= within normal institutional limits; AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal; creatinine <2.5 X institutional upper limit of normal
Exclusion Criteria:
* Patients may not be receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Study Plan
Omeprazole Plus Standard of Care for Prostate Cancer Regimen
EXPERIMENTAL
This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.
DRUG:
Omeprazole 80 mg twice dailyDescription:
Participants will be treated with omeprazole 80 mg twice daily on Day 0. Within 10 days of starting omeprazole, participants will be treated with standard prostate cancer dosing of every three week docetaxel or cabazitaxel based on package insert. Participants that have only had docetaxel will be retreated with docetaxel along with concurrent omeprazole. Patients that have had both docetaxel and cabazitaxel will be retreated with either cabazitaxel or docetaxel (investigators choice) along with concurrent omeprazole. However investigators encourage investigator to choose cabazitaxel in patients previously treated with cabazitaxel.
Outcome Measures
Primary Outcome Measures
Change Radiographic Response - RECIST 1.1
Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Secondary Outcome Measures
Fatty Acid Synthase Activity - Pre Omeprazole Use
Fatty Acid Synthase Activity - Post Omeprazole Use
Prostate Specific Antigen (PSA) Progression
Prostate Specific Antigen (PSA) Response
Patient Reported Outcome - Pain
Timeline
Last Updated
September 19, 2024Start Date
April 7, 2020Today
January 16, 2025Completion Date ( Estimated )
April 1, 2026
Sponsors of this trial
Lead Sponsor
Wake Forest University Health SciencesCollaborating Sponsors
National Cancer Institute (NCI)