New Clinical Trial: Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer

Dr. Beltran
Dr. Beltran

The Weill Cornell Urological Oncology Program has recently opened a new clinical trial for for men with metastatic castrate resistant prostate cancer (CRPC) whose cancer has gotten worse after other treatments. The study is evaluating an experimental drug called cabozantinib (XL184). The sponsor of the study is Exelixis, and the principal investigator at Weill Cornell is Dr. Himisha Beltran.

For more information about the study, please call Renee Khan, RN at (212) 746-1851, e-mail Renee at rek9015@med.cornell.edu.

Key Eligibility
  • Metastatic castration-resistant prostate cancer
  • Evidence of bone metastasis related to prostate cancer
  • Must have received prior treatment with docetaxel and either abiraterone or MDV3100 and have had disease progression on each medication
  • Detailed eligibility reviewed when you contact the study team
Study Details

The purpose of the study is to determine if cabozantinib is effective in prolonging survival compared to the drug prednisone. The study will also evaluate the safety of cabozantinib and how well people with advanced prostate cancer tolerate the drug. In an ongoing study, cabozantinib treatment has resulted in high rates of pain relief and has shown substantial anti-tumor activity. Cabozantinib could provide a valuable new treatment option for men with CRPC who experience disease progression on or after prior therapies.

Treatment Plan

Study participants will be randomly assigned to one of two treatment groups:

  • Group 1: cabozantinib once daily + placebo prednisone twice daily
  • Group 2: Prednisone twice daily + placebo cabozantinib once daily

Participants have a 2/3 chance of receiving cabozantinib (Group 1) and a 1/3 chance of receiving prednisone (Group 2). Participants will not know which treatment they are receiving. Cabozantinib is a capsule and prednisone is a tablet, both taken by mouth.

Participants will continue to receive study treatment as long as they continue to receive clinical benefit and do not experience unacceptable side effects.

Click here to view all current prostate cancer clinical trials in the Department of Medicine.

New Weill Cornell Clinical Trial: Aurora Kinase A Inhibitor MLN8237 in Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

The Urological Oncology Program has recently opened a new, investigator-initiated clinical trial for for men with metastatic castrate resistant prostate cancer and neuroendocrine prostate cancer.  The principal investigator is Dr. Himisha Beltran.

For more information about the study, please call Renee Khan, RN at (212) 746-1851, e-mail Renee at rek9015@med.cornell.edu.

Key Eligibility
  • Men age 18 and older
  • Metastatic neuroendocrine prostate cancer
  • Have had surgical or ongoing chemical castration (men with pure small cell neuroendocrine prostate cancer are not required to have received androgen deprivation therapy or castrate levels of testosterone)
  • Detailed eligibility reviewed when you contact the study team
Study Details

The purpose of the study is to evaluate how well men with neuroendocrine prostate cancer respond to treatment with the experimental drug MLN8237.

MLN8237 (also called alisertib) is a pill taken by mouth. It has been developed to interfere with cell division, which is required for cancer cell growth. Aurora A kinase is an enzyme that may have a role in the progression of prostate cancer to neuroendocrine prostate cancer, which tends to behave aggressively and not respond well to most other therapies used for advanced prostate cancer. MLN8237 works by blocking Aurora A kinase. This may interfere with dividing cells, thereby slowing the growth of cancer and killing cancer cells.

All study participants will receive MLN8237; there is no placebo used in this study.  Participants will take MLN8237 in 21-day cycles:

  •  MLN8237 twice a day for 7 days in a row; after the 7 days of treatment, will not take it again for 2 weeks and then restart the cycle again

Study participants will continue with MLN8237 therapy as long as they are responding to treatment and not experiencing unacceptable side effects.

Weill Cornell Researchers Discover Achilles’ Heel in Lethal Form of Prostate Cancer

Himisha Beltran, MD

Dr. Himisha Beltran of the Weill Cornell Prostate Cancer Program and Dr. Mark A. Rubin, Professor of Pathology and Laboratory Medicine, are leading researchers at Weill Cornell who, along with an international team of researchers, have discovered an Achilles’ heel in an aggressive type of prostate cancer — a vulnerability they say can be attacked by a targeted drug that is already in clinical trials to treat other types of cancers.

In the findings, published in Cancer Discovery, the researchers report that the investigational drug had a dramatic response in animal models of neuroendocrine prostate cancer, and so provides the first hope of an effective human therapy for this lethal cancer. Although neuroendocrine prostate cancer comprises only 2% of initial prostate cancer diagnoses, patients can progress from a more common prostate cancer to a neuroendocrine form as their cancer becomes more advanced.

Specifically, Drs. Beltran and Rubin have discovered that the aurora kinase inhibitor PHA-739358 works against human neuroendocrine prostate cells. To date, the more common adenocarcinoma prostate cancer is treated via androgen suppression therapy. This treatment is utilized well for the more common prostate cancer. But, it is speculated that as the androgen suppression therapy destroys the common cancer cells, neuroendocrine prostate cancer cells grow in their place. If ongoing research confirms this hypothesis, this new molecular pathway could offer hope for the treatment of neuroendocrine prostate cancer.

Click here to read more about the research.