No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
Who this trial is looking for
This trial is looking for men with advanced prostate cancer who have already received docetaxel. Participants will be treated with omeprazole alongside either cabazitaxel or docetaxel to see how these medications work together.
Are You a Good Fit for This Trial?
You may be able to join if
I have castrate refractory prostate cancer and have had docetaxel before
I am 18 years or older
I have a life expectancy of more than 2 months
I am willing to use contraception during and after the study
I can understand and sign an informed consent form
My blood counts and organ function meet study guidelines
You may not be able to join if
I am taking any other investigational agents
I am allergic to omeprazole or taxane drugs
I have an uncontrolled illness that affects my health or compliance
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility 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 …
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.
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