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Prostate Cancer Clinical Trials

ARN-509 for Non-Metastatic Castration-Resistant Prostate Cancer
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer
Status Conditions Phase Study ID
Recruiting Prostate Cancer Phase III NCT01946204
Summary

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study to evaluate the efficacy and safety of ARN-509 versus placebo in adult men with high-risk non-metastatic castration-resistant prostate cancer. Approximately 1200 participants will be randomly assigned in a 2:1 ratio to receive either ARN-509 (treatment arm A) or placebo (treatment arm B). Serial pharmacokinetic blood samples will be collected. Participants will be followed for safety and efficacy and will remain on study treatment until documented radiographic disease progression, development of unacceptable toxicity, or withdrawal of consent. Participants discontinuing study treatment will enter the survival follow-up period where they will be followed for the development of symptomatic progression and initiation of subsequent anti-cancer therapies, until death, loss of follow-up, or withdrawal of consent, whichever comes first. The total study duration will be approximately up to Month 59.


Investigator
Celestia Higano, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
February 13, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • 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.