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Fatty Acid Synthase Inhibitor
Omeprazole for Prostate Cancer (FASN Trial)
Phase 2
Recruiting
Led By Michael Goodman, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
ECOG 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
FASN Trial Summary
This trial tests omeprazole with cabazitaxel or docetaxel to see if it improves treatment effects.
Who is the study for?
Men over 18 with advanced prostate cancer that's gotten worse despite hormone therapy and previous taxane treatment (like docetaxel). They must be fairly active, have good organ function, expect to live more than 2 months, and agree to use birth control. Can't join if they're on other experimental drugs or have serious health issues like heart failure or uncontrolled infections.Check my eligibility
What is being tested?
The trial is testing the effects of omeprazole combined with cabazitaxel or docetaxel chemotherapy on men with castration-resistant prostate cancer. The goal is to see if omeprazole can enhance the effectiveness of chemotherapy.See study design
What are the potential side effects?
Omeprazole may cause stomach pain, constipation, gas, nausea/vomiting; rare but severe side effects include rash, dizziness, kidney problems. Chemotherapy can lead to hair loss, fatigue, increased risk of infection due to low blood cell counts.
FASN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can take care of myself and perform daily activities.
Select...
My cancer has worsened according to specific criteria.
Select...
My prostate cancer is resistant to hormone therapy and I've had taxane treatment.
Select...
My blood counts and liver/kidney functions are within normal ranges.
FASN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change Radiographic Response - RECIST 1.1
Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Secondary outcome measures
Fatty Acid Synthase Activity - Post Omeprazole Use
Fatty Acid Synthase Activity - Pre Omeprazole Use
Patient Reported Outcome - Pain
+2 moreFASN Trial Design
1Treatment groups
Experimental Treatment
Group I: Omeprazole Plus Standard of Care for Prostate Cancer RegimenExperimental Treatment1 Intervention
This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,053 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,075 Patients Enrolled for Prostate Cancer
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,217 Total Patients Enrolled
20 Trials studying Prostate Cancer
1,749 Patients Enrolled for Prostate Cancer
Michael Goodman, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
27 Total Patients Enrolled
Frequently Asked Questions
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