Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Part of paid clinical trials in Salisbury, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04337580
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omeprazole 80 mg twice daily — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 5, 2021
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Omeprazole Plus Standard of Care for Prostate Cancer Regimen
    This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.

Primary Outcome Measure

Change Radiographic Response - RECIST 1.1 [ Time Frame: Up to approximately 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
W.G. Bill Hefner VA Medical CenterSalisburyNorth Carolina28144
Study Coordinator
[email protected]
Michael Goodman, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Study Coordinator
[email protected]
Michael Goodman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salisbury, NC

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
W.G. Bill Hefner VA Medical Center· Salisbury, NCWake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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