Prostate Cancer
Conditions
Brief summary
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
Interventions
DRUGGaleterone
2550 mg galeterone tablets once daily PO
DRUGEnzalutamide
160 mg enzalutamide capsules once daily PO
Sponsors
LTN PHARMACEUTICALS, INC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Progressive metastatic (M1) disease on androgen deprivation therapy * Detectable AR-V7 from circulating tumors (CTCs) * ECOG performance status 0 or 1
Exclusion criteria
* Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide) * Prior treatment with chemotherapy for CRPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression-free survival | ≥ 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | ≥ 8 months |
| Time to Initiation of Cytotoxic Chemotherapy | ≥ 8 months |
Other
| Measure | Time frame |
|---|---|
| Time to PSA progression | ≥ 8 months |
| Skeletal-related Events | ≥ 8 months |
| Best Overall Response by RECIST 1.1 | ≥ 8 months |
| Time to ECOG deterioration | ≥ 8 months |
| Safety measured by clinical safety laboratories and adverse events | ≥ 8 months |
| Prostate Specific Antigen (PSA) Response ≥ 50% | ≥ 8 months |
Countries
Australia, Belgium, Canada, France, Italy, Spain, United Kingdom, United States
Outcome results
None listed