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Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

NCT04337580 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Omeprazole 80 mg twice daily

Participants will be treated with omeprazole 80 mg twice daily on Day 0. Within 10 days of starting omeprazole, participants will be treated with standard prostate cancer dosing of every three week docetaxel or cabazitaxel based on package insert. Participants that have only had docetaxel will be retreated with docetaxel along with concurrent omeprazole. Patients that have had both docetaxel and cabazitaxel will be retreated with either cabazitaxel or docetaxel (investigators choice) along with concurrent omeprazole. However investigators encourage investigator to choose cabazitaxel in patients previously treated with cabazitaxel.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Michael Goodman, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2028-02-29
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04337580 on ClinicalTrials.gov