Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Omeprazole 80 mg twice daily
DrugParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Omeprazole Plus Standard of Care for Prostate Cancer RegimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change Radiographic Response - RECIST 1.1
Response will be defined by RECIST 1.1 as defined by Prostate Cancer Clinical Trials Working Group 3 definition for complete response (CR) - disappearance of all target lesions); partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions); progressive disease (PD) (at least a 20% increase in the sum of diameters or target lesions); stable disease (SD) (neither sufficient shrinkage to qualify for partial response nor sufficient to qualify for progressive disease); or not evaluable (NE).
Time frame
Up to approximately 2 years2
Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Response will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) or not evaluable (NE).
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Prostate Specific Antigen (PSA) Progression
Investigators will collect PSA to determine whether PSA progression is positive or negative. Positive meaning that PSA slope is getting worse over time than it was prior to treatment and negative meaning PSA slope is improving after treatment when compared to baseline.
Time frame
At baseline and up to approximately 2 years2
Prostate Specific Antigen (PSA) Response
Investigators will examine a PSA response rate (baseline on clinical definition of PSA response). In this analysis investigators will determine for each participant if they are a PSA responder (yes/no) and then using this data will estimate a 95% exact Clopper Pearson binomial interval for the PSA response rate.
Time frame
At baseline and up to approximately 2 years3
Patient Reported Outcome - Pain
Participants will report pain intensity at Cycle 1 Day 1 (baseline) compared to Cycle 5, Day 1 and Day 1 of every subsequent cycle on numeric scale of 0-to-10 (0 = no pain, 10 = worse imaginable pain). A paired t-test will be performed to determine whether the Pain score improved or worsened in patients after treatment.
Time frame
At baseline, 12 weeks, and Day 1 of every subsequent cycle (each cycle is 28 days) up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov