Phase 2 N=88 Randomized Treatment

Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer

Hormone-resistant Prostate Cancer · Recurrent Prostate Cancer · Stage IV Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02012296 ↗

Enrolled (actual)

Serious AEs

13.6%

Results posted

Jul 2022

Primary outcome: Primary: PSA Progression-free Survival — 20.8; 16.5 Months — p=0.83

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: enzalutamide (Drug); mifepristone (Drug); laboratory biomarker analysis (Other); pharmacological study (Other)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: University of Chicago
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY PSA Progression-free Survival	20.8; 16.5	0.83
SECONDARY Radiographic PFS	NA; 16.5	0.21
SECONDARY Number of Participants With Positive AR Expression Within Circulating Tumor Cells (CTCs)	16; 8; 5	—
SECONDARY Number of Participants With Positive GR Expression Within Circulating Tumor Cells (CTCs)	17; 8; 5	—
SECONDARY Testosterone	0.6; 21.0	0.0012 sig
SECONDARY Thyroid Stimulating Hormone	-0.121; 0.306	<0.0001 sig
SECONDARY Cortisol	0.072; 0.733	0.0002 sig

Summary

This partially randomized phase I/II trial studies the side effects and best dose of enzalutamide and mifepristone when given together and to see how well they work in treating patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide and mifepristone, may lessen the amount of androgens made by the body. It is not yet known whether enzalutamide is more effective with or without mifepristone in treating patients with prostate cancer.

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed prostate cancer
Evidence of castrate testosterone level = 5 years from enrollment
Blood pressure that is not controlled despite > 2 oral agents (systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 documented during the screening period with no subsequent blood pressure readings 450 msec
Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
Active psychiatric illness/social situations that would limit compliance with protocol requirements
New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
Concurrent therapy with strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) due to concerning possible drug-drug interactions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02012296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.