Condition: Castration-Resistant Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03344211

Sponsor: University of Southern California

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic
• Castration resistance will be defined as the development of disease progression, defined as one of the following:
• Rising PSA x 2 values >= 2 weeks apart; minimum absolute PSA value 2 ng/mL
• Radiographic progression, with at least 1 new site of metastasis
• Symptomatic progression (ex: increase in pain despite stable imaging) AND despite ongoing luteinizing hormone-releasing hormone (LHRH) therapy OR testosterone level < 50
• Men must have osseous metastases, but the presence of visceral metastases will not exclude patients from participation
• Prior external beam radiation therapy (> 4 weeks prior to enrollment) for palliation of osseous metastatic disease is allowed, provided there is at least one osseous metastasis which has not been irradiated and which can be biopsied
• No prior docetaxel or cabazitaxel chemotherapy for metastatic castration-resistant prostate cancer (mCRPC) (men treated with prior docetaxel administered as up-front therapy with androgen deprivation therapy [ADT] > 6 months ago will be eligible); prior abiraterone is allowed
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Hemoglobin >= 9.5 g/dL
• Absolute neutrophil count >= 1,500
• Platelets >= 100,000
• Total bilirubin within normal institutional limits
• Creatinine clearance (calculated or measured) > 30 mL/min
• At least one risk factor predicting higher likelihood of bone marrow sample yield: elevated alkaline phosphatase, low hemoglobin, or elevated lactate dehydrogenase (LDH)
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Prior treatment with docetaxel or cabazitaxel for mCRPC
• Prior treatment with ARN-509 or enzalutamide (there is a grace period for men who wish to enroll and who have recently started enzalutamide for the first time but have taken less than 15 days of therapy)
• Concurrent use of androgen deprivation therapy aside from LHRH agonist or antagonist (i.e. bicalutamide, flutamide, nilutamide, abiraterone, ketoconazole, estrogen); there will be a 2 week wash-out period from the last dose of any of these agents until the first dose of enzalutamide on study; patients who have just started enzalutamide for fewer than 5 doses prior to enrollment in the trial are still considered eligible and not subject to wash-out
• Concurrent oral corticosteroid use aside from adrenal replacement, or use of other immunosuppressive agents (ex: infliximab); topical or inhaled steroids will be allowed
• Received systemic therapy with radionuclides (e.g., strontium-89, samarium- 153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
• History of seizures except for remote with specific etiology which has resolved (ex: alcohol induced seizure); transient ischemic attack (TIA) or cerebrovascular accident (CVA) within last 6 months
• Known untreated central nervous system (CNS) metastases; leptomeningeal disease will be an absolute exclusion criterion due to limited life expectancy
• Chronic diarrhea > grade 1, or a diagnosis of Crohn?s or ulcerative colitis
• Known hepatitis (hep) B or C, or known cirrhosis (screening for viral hepatitis is not required)
• Uncontrolled intercurrent illness such as infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness which would limit compliance with study requirements
• Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression

View trial on ClinicalTrials.gov