Other than skin cancer, prostate cancer is the most common cancer in American men. The American Cancer Society estimates that in 2013, about 238,590 new cases of prostate cancer will be diagnosed, and around 29,720 men will die of prostate cancer; some one in six men will be diagnosed with prostate cancer during his lifetime. Due to its widespread incidence and unmet medical need, prostate cancer is the target of a significant proportion of clinical research and ranks fifth in terms of number of Development Programs in phase I to phase III, after breast cancer, leukemia, colorectal cancer and lymphoma.
Prostate cancer faces almost all the main challenges typically found in oncology clinical development, including:
- Operational: The prostate cancer patient pathway has always been a critical component of clinical trials for this patient population, involving urologists, medical oncologists, as well as primary care physicians. Mapping this pathway at various sites becomes crucial for the recruitment and retention of patients in prostate cancer studies.
- Medical: For both non-metastatic castration resistant prostate cancer (a constantly growing patient population, in need of innovative effective drugs) and metastatic castration resistant prostate cancer there is a high unmet clinical need for novel therapies aimed at new molecular targets.
- Scientific: As we enter the era of personalized medicine, it is essential to identify predictive biomarkers for currently approved therapies and for those in development. Recently, many therapeutic agents for prostate cancer have been approved that target the androgen receptor and/or the prostate tumor microenvironment. Each of these therapies has modestly increased patient survival. A better understanding of when in the course of prostate cancer progression specific therapies should be applied, and of what biomarkers indicate when resistance arises, would almost certainly improve outcomes achieved by these therapies.
- Study population definition: The Castration Resistant Prostate Cancer (CRPC) population can be divided in four main subsets of patients: those without evidence of metastatic involvement (M0); those with metastatic (M1) asymptomatic or mildly symptomatic disease that can postpone chemotherapy; symptomatic M1 patients eligible to receive the standard chemotherapy; and M1 patients post-chemotherapy.
- Imaging Methodology: In the setting of CRPC, approved drugs, including cytotoxic agents, have been shown to provide a benefit in terms of disease control that translates into prolonged overall survival (OS). The disease control includes tumor shrinkage and disease stabilization, and requires a careful and unbiased assessment to accurately evaluate the non-progressing pool of patients. In addition, the study population has to be defined as non-metastatic or metastatic. Therefore, there is the need for standardized, high resolution imaging techniques and for centralized recording of outcomes to ensure maximum quality.
Understanding these key challenges is the first step to successfully manage prostate cancer trials.
This white paper is a detailed analysis of all these aspects, offering suggestions on how to manage trials effectively in this indication.