Pfizer and Astellas Pharma have reported positive results from a Phase III clinical trial (PROSPER) of Xtandi (enzalutamide) in combination with androgen deprivation therapy (ADT) to treat patients with non-metastatic (M0) castration-resistant prostate cancer (CRPC).

Enzalutamide is an androgen receptor inhibitor being developed to block various steps in the receptor’s signalling pathway within the tumour cell.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The trial has met the primary endpoint with a statistically significant improvement in metastasis-free survival (MFS).

Conducted at trial sites across the US, Canada, Europe, South America and Asia Pacific, the PROSPER trial compared the Xtandi (160mg once daily) and ADT combination with ADT alone in 1,400 subjects.

"Xtandi is already established as a standard of care for men with metastatic CRPC based on the results of prior studies."

The Phase III trial recruited patients with cancer progression even after ADT and without any symptoms, previous or present evidence of metastatic disease.

See Also:

A preliminary safety analysis of the PROSPER trial is reported to have indicated a consistent profile of Xtandi compared to prior clinical trials.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Pfizer Global Product Development Oncology chief development officer Mace Rothenberg said: “Xtandi is already established as a standard of care for men with metastatic CRPC based on the results of prior studies, such as AFFIRM and PREVAIL, which demonstrated that Xtandi delayed disease progression and improved overall survival in men with clinically detectable metastatic disease.”

Xtandi is being further studied in ongoing ARCHES trial for metastatic hormone-sensitive prostate cancer and EMBARK trial for the treatment of non-metastatic hormone-sensitive prostate cancer.

In previous trials for metastatic CRPC, the drug candidate showed a statistically significant overall survival benefit.