Leadership: The Prostate Cancer Clinical Trials Consortium (PCCTC) brings together leading prostate cancer investigators from top research institutions across the country to simplify collaborations to develop helpful treatment faster. Principal Investigator Howard I. Scher, M.D., Chief of Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York, has clinical expertise in treating patients with prostate cancer and researching the disease, and has published more than 350 scientific articles on the subject. He has been the lead researcher on numerous prostate cancer studies and currently serves on the editorial boards of three medical journals. For the last 2½ years, he has directed the PCCTC.

Types of Patients: MSKCC recruits men into research studies who have prostate cancer and have had disease progression despite other treatments, have types of disease for which no accepted therapy exists, or cannot have standard therapy because it is too toxic or too risky. Because patient diversity, including racial-ethnic diversity, is one consideration for our trials, we are actively seeking African American men, a group that has had high rates of prostate cancer. All patients in our trials gain access to our diagnostic resources and receive treatments that are not otherwise available, which could extend their lives or improve their quality of life.

Consortium Structure: MSKCC serves as the coordinating center for the PCCTC, and we oversee data management, study development and implementation, ethical and scientific approvals, and regulatory compliance. We also negotiate contracts for the consortium and organize communications among researchers to further the scientific agenda. The Clinical Consortium Committee (CCC) includes lead investigators from all of the participating institutions in the PCCTC and is the scientific backbone of the PCCTC. The CCC determines scientific priorities, selects clinical trials to be implemented, and sets standards for the design, conduct, and quality control.

Initial Clinical Trials: An important area of research in which we are involved is the assessment of pain in men with metastatic prostate cancer. Using a questionnaire that was developed at consortium-member site M. D. Anderson Cancer Center and refined at MSKCC, we will evaluate the prevalence of pain in patients across the consortium, the clinical significance of pain score changes, and the effects of pain medication use in this population. Our goal is to develop a standardized approach to pain measurement that could be used toward drug approval and labeling, and such a model is currently planned for use in a phase II trial. Separately, our second trial is based on our previous research in the field of androgen receptors. Using one of the agents developed by investigators at our new Human Oncology and Pathogenesis Program, we are developing a series of new drugs designed to target specific actions that may slow the development of prostate cancer.

Impact: We have led the PCCTC in evaluating 65 protocols, opened 43 clinical trials, and recruited 1,106 patients to these trials. We have tested new drugs and investigated new theories of cancer progression, many for the first time in man or the first time in prostate cancer. Our members have presented their findings at professional meetings and have published manuscripts in scientific journals. We have co-developed a number of trials with industry sponsors, and we leverage major federal and foundation programs, most notably NIH P01 and U01 awards, Specialized Programs of Research Excellence (SPORE) grants in prostate cancer, and funding from the Prostate Cancer Foundation. In the past 2½ years, we have begun discovering new ways to improve the detection, diagnosis, and treatment of prostate cancer that will benefit many patients in the foreseeable future.