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Omeprazole with Docetaxel or Cabazitaxel for Castration-Resistant Prostate Cancer

This study is looking at how omeprazole, a medication often used for heartburn, affects the treatment of castration-resistant prostate cancer when given with either docetaxel or cabazitaxel. Researchers believe omeprazole might help these chemotherapy drugs work better. You may be able to join if you are a man aged 18 or older with castration-resistant prostate cancer that has progressed after prior docetaxel treatment. The study aims to see if adding omeprazole can lead to a significant reduction in tumor size and bone metastases. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 50 participants. The phase of the study is not specified.
What's involved
Participants will take omeprazole twice daily, starting 10 days before beginning standard doses of docetaxel or cabazitaxel. Pain levels will be measured at specific times throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Changes in radiographic response and bone metastasis response will be measured for up to approximately 2 years.

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NCT04337580

Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~50 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Omeprazole 80 mg twice daily

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change Radiographic Response - RECIST 1.1
Measured over Up to approximately 2 years
+1 more outcome measured

Conditions

Prostate Cancer
Refractory Cancer
Castration Resistant Prostatic Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 1 states
North Carolina2

Study leadership

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

Who to contact

Study Coordinator
[email protected]
336-716-5772
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change Radiographic Response - RECIST 1.1Up to approximately 2 years

    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).

  • Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)Up to approximately 2 years

    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).