Prostate Cancer Clinical Trial
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.
This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and target patient population and Part 2 will be expansion of the dose and patient population selected in Part 1. For eligible patients, there will be an optional extension dosing following the completion of Part 1 or Part 2 of the trial.
Obtaining of informed consent and screening may be performed up to 28 days prior to enrollment. Each patient will be able to receive his specified regimen for 3 consecutive cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit assessments will be used to determine outcome and dosing may continue up to an additional 2 weeks until the results of all assessments are obtained. Eligible patients may continue treatment in an optional extension period following the completion of the primary parts of this trial.
Histologically or cytologically confirmed adenocarcinoma of the prostate
Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
Demonstration of progression while on androgen blockade
Eastern Cooperative Oncology Group (ECOG) Performance Status <2
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
Prior chemotherapy (unless allowed for some study arms)
Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
Prior use of any chronic systemic glucocorticoids .
Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
Prior treatment with Alpharadin® (Xofigo®)
Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
Severe systemic diseases or active uncontrolled illnesses.
Abnormal heart function
Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
The patient has known allergy to any of the treatment components
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
History of excessive alcohol consumption
Use of any substance known to cause AME
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 23 Locations for this study
Los Angeles California, 90095, United States
San Bernardino California, 92404, United States
Boca Raton Florida, 33486, United States
New Orleans Louisiana, 70112, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21205, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Omaha Nebraska, 68130, United States
Brick New Jersey, 08724, United States
Lawrenceville New Jersey, 08648, United States
Buffalo New York, 14263, United States
New York New York, 10029, United States
Concord North Carolina, 28025, United States
Greenville South Carolina, 29605, United States
Myrtle Beach South Carolina, 29572, United States
Dallas Texas, 75230, United States
Seattle Washington, 98136, United States
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M4N 3, Canada
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.