Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

NCT04337580 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00068039P30CA012197WFBCC 85220
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Refractory Cancer; Prostate Cancer; Castration Resistant Prostatic Cancer

Outcome Measures

Primary Outcomes (2)

• Change Radiographic Response - RECIST 1.1

  Response will be defined by RECIST 1.1 as defined by Prostate Cancer Clinical Trials Working Group 3 definition for complete response (CR) - disappearance of all target lesions); partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions); progressive disease (PD) (at least a 20% increase in the sum of diameters or target lesions); stable disease (SD) (neither sufficient shrinkage to qualify for partial response nor sufficient to qualify for progressive disease); or not evaluable (NE).

  Up to approximately 2 years

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

  Response will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) or not evaluable (NE).

  Up to approximately 2 years

Secondary Outcomes (3)

• Prostate Specific Antigen (PSA) Progression

  At baseline and up to approximately 2 years

• Prostate Specific Antigen (PSA) Response

  At baseline and up to approximately 2 years

• Patient Reported Outcome - Pain

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

Study Arms (1)

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

Interventions

Omeprazole 80 mg twice daily DRUG

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.

Omeprazole Plus Standard of Care for Prostate Cancer Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

W.G. Bill Hefner VA Medical Center

Salisbury, North Carolina, 28144, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Prostatic Neoplasms, Castration-Resistant

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael Goodman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 7, 2020
• Study Start: March 5, 2021
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)