A Phase III, Randomized, Doubleblind, Controlled Trial of Cabozantinib (XL184) vs. Mitoxantrone Plus Prednisone in Men with Previously Treated Symptomatic Castration-resistant Prostate Cancer

This randomized phase III trial will evaluate the effects of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Eligibility criteria

• 18 years or older with histological or cytological diagnosis of castration resistant prostate cancer with a serum testosterone of less than 50 ng/dL.
• Evidence of bone metastasis related to prostate cancer on bone scans.
• Documented pain from bone metastases that requires opioid narcotic intervention.
• Adopted a narcotic regimen that consists of one sustained release opioid agent taken daily for chronic pain and access to one immediate release opioid agent for breakthrough pain.
• Received prior docetaxel and either abiraterone orMDV3100 treatment and has evidence of investigator assessed prostate cancer progression on each agent independently.
• Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.
• Recovered from toxicities related to any prior treatments, unless the toxicities are clinically nonsignificant or easily manageable.
• Adequate organ and marrow function.
• A left-ventricular ejection fraction of >/= 50%assessed by echocardiogram or multigated acquisition scan.

Peter Van Veldhuizen, MD, Principal Investigator

Learn more about this clinical trial.