New clinical study data could redefine treatment for mCRPC patients

Jun 7 2016

Janssen-Cilag International NV today announced that data from an interim analysis of The Prostate Cancer Registry, Europe’s first and largest prospective study of men with metastatic castration-resistant prostate cancer (mCRPC), indicate that the presence of distant metastases (M1) at initial diagnosis may be a critical indicator of future treatment and prognosis for mCRPC patients.

The data, presented today at the American Society of Clinical Oncology (ASCO) 2016 Congress, Chicago, USA, described characteristics at study entry of men with mCRPC who had distant metastases at primary diagnosis (M1) as compared to those whose cancer had not metastasised at primary diagnosis (M0). The data demonstrated higher prostate-specific antigen (PSA) levels, increased incidence of bone lesions and slightly worse level of functioning, in terms of their ability to care for themselves, daily activity, and physical ability (measured by the ECOG Performance Status Scale) for patients with M1 at initial diagnosis compared to patients with no metastases (M0) at initial diagnosis.

• PSA levels were 34.4% higher (61.7 ng/mL vs 45.9 ng/mL) for M1 vs M0
• Incidence of bone lesions (>5) was 24% higher (51% vs 41%) for M1 vs M0
• The proportion of men with an ECOG Performance Status of >2 was 39% higher (17% vs 13%) for M1 vs M0

“These data can help to better inform the way we treat mCRPC patients. It demonstrates that patients who present with metastases at diagnosis require particularly close attention from healthcare professionals to tackle the disease head on with prompt and effective treatment for the best possible outcome,” said Dr Simon Chowdhury, Guy’s Hospital, London. “Real world data, such as these, provide us with valuable insight into the true patient journey. They include a wider population, such as men of a broader age range and with other existing health problems, than the more restricted and closely monitored populations seen in interventional clinical trials.”

The Prostate Cancer Registry has enrolled over 3,000 mCRPC patients in 199 centres across 16 European countries. It aims to address the key medical and scientific questions concerning the optimal care of mCRPC patients in routine practice. The size of the database will enable analysis on sub-populations relevant to healthcare professionals. In this dataset, 1323 patients with mCRPC were analysed, including 549 who had M1 (41.5%) and 526 who had M0 (39.8%) disease at initial diagnosis, and 248 men for whom state of metastasis was not measureable (Mx, 18.7%) at initial diagnosis. Follow-up of these patients over time will clarify how these clinical differences and subsequent treatment may affect clinical outcome.

Jane Griffiths, Company Group Chairman, Janssen Europe, the Middle East and Africa (EMEA) said:

Janssen is proud to be supporting The Prostate Cancer Registry, which is the largest of its kind in Europe. As there are currently limited data available on the everyday experience of mCRPC patients, we hope that the insights from the trial will lead to an improvement in the quality of care and prognosis for men with mCRPC.

Prostate cancer is the most commonly diagnosed cancer in men, with over 400,000 new cases diagnosed in Europe each year. Latest prostate cancer figures show that there are currently three million men living with the disease in Europe.