A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases. This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : cabozantinib
  • drug : prednisone
  • drug : mitoxantrone

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone 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 one immediate release opioid agent for breakthrough pain. - Received prior docetaxel and either abiraterone or MDV3100 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 non significant or easily manageable. - Adequate organ and marrow function. - A left-ventricular ejection fraction (LVEF) of >/= 50% assessed by echocardiogram or MUGA (multigated acquisition scan). - Capable of understanding and complying with the protocol requirements (including having the ability to access an interactive voice recognition system and self-report pain and narcotic use) and signed the informed consent form. - Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study treatment.

External Links

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Contact information

Primary Contact:

Denise Haas 6507361252

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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