Using omeprazole to enhance treatment for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of combining omeprazole, a fatty acid synthase inhibitor, with taxane therapies (cabazitaxel or docetaxel) in patients with castration-resistant prostate cancer who have previously failed these treatments. The primary objective is to assess the overall response rate to this combination therapy, while secondary objectives include evaluating the pharmacodynamics of omeprazole using PET/CT imaging and measuring prostate-specific antigen response rates. Participants will also report their pain levels throughout the treatment cycles. The study aims to determine if omeprazole can improve the efficacy of existing taxane therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• W.G. Bill Hefner VA Medical Center
  Salisbury, North Carolina, United States Recruiting
• Wake Forest Baptist Comprehensive Cancer Center
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Michael Goodman, MD — Wake Forest University Health Sciences
• Study coordinator: Study Coordinator
• Email: Emily.Teal@advocatehealth.org
• Phone: 336-716-5772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.