Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Clinicaltrials.gov ID: NCT04337580
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 20

Conditions

Prostate Cancer, Refractory Cancer, Castration Resistant Prostatic Cancer

Drugs

Omeprazole 80 mg twice daily

Summary

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

Principal Investigator

  • Michael Goodman, MD

Status

  • RECRUITING

Contact Person

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 daily

    Description:

    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

Time Frame: At 3, 6 and 9 months

Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

Time Frame: At 3, 6 and 9 months

Secondary Outcome Measures

Fatty Acid Synthase Activity - Pre Omeprazole Use

Time Frame: At baseline

Fatty Acid Synthase Activity - Post Omeprazole Use

Time Frame: Up to approximately 2 years

Prostate Specific Antigen (PSA) Progression

Time Frame: At baseline and up to approximately 2 years

Prostate Specific Antigen (PSA) Response

Time Frame: At baseline and up to approximately 2 years

Patient Reported Outcome - Pain

Time Frame: At baseline, 12 weeks, and Day 1 of every subsequent cycle (each cycle is 28 days) up to approximately 2 years

Timeline

  • Last Updated
    September 19, 2024
  • Start Date
    April 7, 2020
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    April 1, 2026

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