Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer (FASN)
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|ClinicalTrials.gov Identifier: NCT04337580|
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : July 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Refractory Cancer Castration Resistant Prostatic Cancer||Drug: Omeprazole 80 mg twice daily||Phase 2|
Primary Objective(s): Obtain Overall Response Rate (ORR) to taxane therapy by adding the fatty acid synthase inhibitor, omeprazole to the current "failing" taxane regimen in 15% of subjects using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, defined by partial response (PR) or complete response (CR)
Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer Center main campus):
- Pharmacodynamics-demonstrate omeprazole in vivo fatty acid synthase inhibition by 11C-Acetate PET/CT (3-6) Non-invasive approach to demonstrate the fatty acid synthase inhibitor (omeprazole) is hitting its target
- Obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to the current "failing" taxane regimen. (16)
- Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS) at Baseline, Cycle 5, Cycle 12, and every cycle thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||FASN Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer Salvaging Taxane Failure|
|Actual Study Start Date :||March 5, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Omeprazole Plus Standard of Care for Prostate Cancer Regimen
This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.
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.
- Change Radiographic Response - RECIST 1.1 [ Time Frame: At 3, 6 and 9 months ]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).
- Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3) [ Time Frame: At 3, 6 and 9 months ]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).
- Fatty Acid Synthase Activity - Pre Omeprazole Use [ Time Frame: At baseline ]Performed only on the first 10 participants by utilizing the 11C acetate tracer in the PET scan to evaluate the fatty acid synthase activity prior to omeprazole by examining changes in the values of standardized uptake. we will perform a two-sample t-test to see whether the change in SUV values is different between patients with an objective response versus those without an objective response.
- Fatty Acid Synthase Activity - Post Omeprazole Use [ Time Frame: Up to approximately 2 years ]Evaluating the first 10 participants by utilizing the 11C acetate tracer in the PET scan to evaluate the fatty acid synthase activity prior to omeprazole by examining changes in the values of standardized uptake. we will perform a two-sample t-test to see whether the change in SUV values is different between patients with an objective response versus those without an objective response.
- Prostate Specific Antigen (PSA) Progression [ Time Frame: At baseline and up to approximately 2 years ]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.
- Prostate Specific Antigen (PSA) Response [ Time Frame: At baseline and up to approximately 2 years ]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.
- Patient Reported Outcome - Pain [ Time Frame: At baseline, 12 weeks, and Day 1 of every subsequent cycle (each cycle is 28 days) up to approximately 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337580
|Contact: Study Nurseemail@example.com|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Study Nurse firstname.lastname@example.org|
|Principal Investigator: Michael Goodman, MD|
|Principal Investigator:||Michael Goodman, MD||Wake Forest University Health Sciences|