Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Description

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.

Conditions

Prostate Cancer, Refractory Cancer, Castration Resistant Prostatic Cancer

Study Overview

Study Details

Study overview

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.

A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer

Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Salisbury

W.G. Bill Hefner VA Medical Center, Salisbury, North Carolina, United States, 28144

Winston-Salem

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Michael Goodman, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2026-04