Prostate Cancer Clinical Trials
|Closed||Prostate Cancer||Phase II||NCT01709734|
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
- Liver metastases
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.