A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration
resistant prostate cancer (CRPC) patients.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Inclusion Criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the prostate
2. Ongoing androgen blockade demonstrated by serum testosterone concentration of less
than 50 ng/dL
3. Demonstration of progression while on androgen blockade
4. Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Exclusion Criteria:
1. Depending upon patient prior treatment the following apply:
- Prior treatment with CYP17 inhibitors or AR antagonists (e. g. abiraterone,
TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone) - Treatment naïve
only
- Prior treatment with CYP17 inhibitors (e. g. TAK-700, ketoconazole*) or AR
antagonists (e. g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory
only
- Prior treatment with CYP17 inhibitors (e. g. abiraterone, TAK-700, ketoconazole*)
or AR antagonists (e. g. ARN - 509) or galeterone - enzalutamide refractory only
2. Prior chemotherapy (unless allowed for some study arms)
3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
4. Prior use of any chronic systemic glucocorticoids .
5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of
enrollment
6. Prior treatment with Alpharadin® (Xofigo®)
7. Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to
enrollment
8. Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks
prior to enrollment
9. Severe systemic diseases or active uncontrolled illnesses.
10. Abnormal heart function
11. Liver metastases
12. Brain metastases (unless stable disease >3 mos. by scan without additional
CNS-directed therapy)
13. The patient has known allergy to any of the treatment components
14. Any physical or mental condition or social situation that in the opinion of the
Investigator may interfere with the patient's ability to comply with the trial
procedures
15. History of excessive alcohol consumption
16. Use of any substance known to cause AME
BC Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada
UCLA David Geffen School of Medicine, Los Angeles, California 90095-7384, United States
San Bernardino Urological Associates, San Bernardino, California 92404, United States
Raton Regional Hospital, Lynn Cancer Institute, Boca Raton, Florida 33486, United States
Tulane Cancer Center, New Orleans, Louisiana 70112, United States
AAHS Research Institute, Annapolis, Maryland 21401, United States
Sidney Kimmel Johns Hopkins, Baltimore, Maryland 21205, United States
University of Maryland, Baltimore, Maryland 21201, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Karmanos Cancer Institute, Detroit, Michigan 48201, United States
Urology Cancer Center and GU Research Network, Omaha, Nebraska 68130, United States
Coastal Urology Associates, Brick, New Jersey 08724, United States
Premier Urology Associates, LLC, Lawrenceville, New Jersey 08648, United States
Roswell Park Center Institute, Buffalo, New York 14263, United States
Mount Sinai, New York, New York 10029, United States
Carolina Clinical Trials, Concord, North Carolina 28025, United States
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
Greenville Hospital System University Medical Center, Greenville, South Carolina 29605, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States
Texas Urology, Carollton, Texas 75234, United States
Urology Clinics of North Texas, Dallas, Texas 75230, United States
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington 98136, United States