A Study of ARN-509 in Men With Non-Metastatic Castration-Resistant Prostate Cancer

Status: Recruiting
Diagnosis: Prostate Cancer
NCT ID: NCT01946204 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-068


The purpose of this study is to evaluate the efficacy and safety of ARN-509 in adult men with high-risk non-metastatic castration-resistant prostate cancer.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Matthew Smith, MD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases - Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy/post orchiectomy - Maintain castrate levels of testosterone within 4 weeks prior to randomization and throughout the study - Patients currently receiving bone loss prevention treatment with bone-sparing agents must be on stable doses for at least 4 weeks prior to randomization - Patients who received a first generation anti-androgen as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease progression off the anti-androgen for at least 4 weeks prior to randomization - At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors, estrogens, and any other anti-cancer therapy prior to randomization - At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization - Eastern Cooperative Oncology Group Performance Status 0 or 1 - Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade <= 1 or baseline prior to randomization - Adequate organ function according to protocol-defined criteria - Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility Exclusion Criteria: - Presence of confirmed distant metastases, including central nervous system and vertebral or meningeal involvement - Symptomatic local or regional disease requiring medical intervention - Prior treatment with second generation anti-androgens - Prior treatment with CYP17 inhibitors - Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer - Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting - History of seizure or condition that may pre-dispose to seizure - Concurrent therapy with protocol-defined excluded medications - History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months prior to randomization; uncontrolled hypertension; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures
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