Recruiting
Phase 2

Fatty Acid Synthase

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04337580

Conditions

Prostate Cancer

Refractory Cancer

Castration Resistant Prostatic Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Omeprazole 80 mg twice daily

Study Details

Brief 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.

Conditions

Prostate Cancer

Refractory Cancer

Castration Resistant Prostatic Cancer

Study ID

NCT04337580

Start date

Mar 5, 2021

Status verified date

Feb, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have castrate refractory prostate cancer with prior docetaxel treatment which was used in the castrate refractory setting
  • Cancer Progression as defined by prostate cancer working group 3 (PCWG3) any type- prostate specific antigen only, bone only +nodal, nodal only or new lesions
  • 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 three (3) months after study treatment discontinuation.
  • 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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Omeprazole Plus Standard of Care for Prostate Cancer Regimen

This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.

Interventions

Omeprazole 80 mg twice daily

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.

Primary outcome measure

  • Change Radiographic Response - RECIST 1.1 [ Time Frame: Up to approximately 2 years ]
  • Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Study Coordinator

336-716-5772Emily.Teal@advocatehealth.org

Locations

W.G. Bill Hefner VA Medical Center

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Study Coordinator

Emily.Teal@advocatehealth.org

Principal Investigator:

Michael Goodman, MD

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Study Coordinator

Emily.Teal@advocatehealth.org

Principal Investigator:

Michael Goodman, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-13.