Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Official Title

A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients With Metastatic Castration-Resistant Prostate Cancer

Summary:

The purpose of this study is to find out what effects a new drug, palbociclib, has on prostate cancer and will look at the side effects of treatment with palbociclib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by palbociclib and to see how the cancer cells respond to palbociclib.

Trial Description

Primary Outcome:

• Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment

Secondary Outcome:

• Effect of Palbociclib on PSA decline based on decrease in PSA test values from the baseline value
• Objective response determined by RECIST 1.1
• Progression-free survival
• Overall survival
• Number and severity of adverse events

The standard or usual treatment for this disease may be chemotherapy or other types of treatment to slow the spread of the disease and relieve some symptoms of cancer. Palbociclib is a new type of drug for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. Palbociclib has been shown to help patients with breast cancer but it is not known if the drug is useful for treating prostate cancer.

View this trial on ClinicalTrials.gov