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Drug Makers Start Prostate Cancer Patient Registry

Micropgraph of prostate cancer

Micrograph of prostatic acinar adenocarcinoma, the most common form of prostate cancer (Nephron, Wikimedia Commons)

17 June 2015. Two companies that developed a drug to treat prostate cancer, began enrolling individuals into a registry of people with prostate cancer to track their quality of care. Astellas U.S., a division of Astellas Pharma in Tokyo, and Medivation Inc., a biotechnology company in San Francisco, created the registry to better understand treatment patterns and unique requirements of people with castrate-resistant prostate cancer.

Prostate cancer is the second most common form of cancer among men, following skin cancer, affecting more than 2 million men in the U.S. According to American Cancer Society, nearly 221,000 new cases of prostate cancer are expected in 2015, resulting in more than 27,500 deaths. The disease affects mainly older men; those age 65 and over account for 6 of every 10 cases of prostate cancer.

In some cases prostate cancer continues growing even after hormone therapy to reduce testosterone to levels equivalent of castration, a condition called castrate-resistant prostate cancer or CRPC. When the cancer metastasizes, or spreads to other parts of the body, treatment options are more limited. For these cases, Astellas and Medivation developed enzalutamide, a different type of hormone therapy, marketed under the brand name Xtandi.

Both Astellas and Medivation are developing other cancer drugs, and support investigator-sponsored studies related to enzalutamide. The new patient registry, say the companies, is designed to better understand the needs of prostate cancer patients, particularly those with advanced cases of the disease. The study — called Treatment Registry for Outcomes in CRPC Patients or Trumpet — aims to describe patterns of care and disease assessment methods, and  identify factors influencing physician treatment decisions and settings, as well as associate patient characteristics and clinical outcomes with these factors and patterns.

Trumpet plans to enroll 2,000 men with castrate-resistant prostate cancer and track their experiences with the disease for up to 6 years. Caregivers of the patients will also be enrolled. The study expects to track treatment decisions by physicians, factors, behind the decisions, and patterns of treatments, such as timing and settings of assessments, such as prostate specific antigen or PSA tests. The study also plans to gathers data through a series of health-related quality of life questionnaires, such as work productivity, anxiety, pain, and service satisfaction.

Jeffrey Bloss, an Astellas vice-president for global development, notes in a company statement that creation of treatments is only part of their solution. “The insights from Trumpet can directly impact our research and increase our understanding of important treatment considerations,” says Bloss. “While there have been many treatment advances in prostate cancer over the past few years, there is still a great deal for us to learn.”

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