Using omeprazole to enhance treatment for advanced prostate cancer
A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer
PHASE2 · Wake Forest University Health Sciences · NCT04337580
This study is testing if adding omeprazole to taxane treatments can help men with advanced prostate cancer who haven't responded to these therapies before.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 2 sites (Salisbury, North Carolina and 1 other locations) |
| Trial ID | NCT04337580 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 or older with castration-resistant prostate cancer who have previously undergone taxane treatment.
Not a fit: Patients currently receiving other investigational agents or those with significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that enhances the effectiveness of existing therapies for patients with advanced prostate cancer.
How similar studies have performed: While the combination of omeprazole with taxane therapies is a novel approach, previous studies have explored fatty acid synthase inhibition in cancer treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Salisbury, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Refractory Cancer, Castration Resistant Prostatic Cancer