A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Prostate Cancer
NCT ID: NCT01709734 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-518


A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Glenn Bubley, MD, Beth Israel Deaconess Medical Center
Philip Saylor, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: 1. Male age > 18 years 2. Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology) 3. Ongoing androgen blockade (therapy with gonadotropin-releasing hormone (GnRH) analogues, or orchiectomy) demonstrated by serum testosterone concentration of less than 50 ng/dL. 4. Demonstration of progression while on androgen blockade (based upon PCWG2 guidelines). 5. Eastern Cooperative Oncology Group (ECOG) Performance Status <2 Exclusion Criteria: 1. Prior treatment with androgen directed hormonal therapies (prior abiraterone treatment allowed for some study arms) 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® (radium-223 chloride) 7. Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment 8. Treatment with Coumadin® (warfarin sodium) 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
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