DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

The Prostate Cancer Clinical Trials Consortium: Application for Coordinating Center with Clinical Research Site Option

Principal Investigator: SCHER, HOWARD
Institution Receiving Award: SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH
Program: PCRP
Proposal Number: PC171115
Award Number: W81XWH-18-2-0060
Funding Mechanism: Clinical Consortium Award - Coordinating Center with a Clinical Research Site
Partnering Awards:
Award Amount: $6,137,932.00


PUBLIC ABSTRACT

Accelerating Drug Development Through Multicenter Collaboration: The Prostate Cancer Clinical Trials Consortium (PCCTC) brings together the nation’s leading prostate cancer investigators to fulfill a single mission: to design, implement, and complete innovative clinical trials in prostate cancer, translating scientific discoveries to improved standards of care. Since its inception in 2005, the PCCTC has been led by Principal Investigator Howard I. Scher, M.D., Chief of the Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center (MSK). Dr. Scher’s renowned insight into prostate cancer biology and expertise in treating men with advanced disease allows the PCCTC to select the most promising drug development opportunities based on the strength of the science.

Multicenter collaboration and the consortium’s proven ability to accelerate and streamline the clinical trial process are made possible through the constant refinement of the PCCTC Coordinating Center’s infrastructure. To allow the PCCTC to fulfill its mission, the Coordinating Center addresses the scientific, legal, regulatory, data, budgetary, and management obstacles of investigators throughout its network of 35 clinical research sites. Our approach has enabled the PCCTC to evaluate 246 protocols, approve 188 for activation, and enroll over 6,066 men in 178 trials, of which 140 have been completed as of August 2017. Critically, we have contributed to the advancement of 12 therapeutic candidates to phase III study, two of which (Zytiga, Xtandi) have been Food and Drug Administration (FDA)-approved for treatment of men with castration-resistant prostate cancer (CRPC).

Targeting Unmet Needs in Prostate Cancer Clinical Care: MSK recruits into research studies men who have prostate cancer and have had disease progression despite other treatments; men who have types of disease for which no accepted therapy exists; or men who cannot have standard therapy because it is too toxic or risky. The PCCTC has also tasked itself with improving care for patients from disproportionately affected populations. As such, MSK and the entire consortium are actively seeking African-American men, a group that has had high rates of prostate cancer. Equally important has been our work with regulatory authorities (FDA and the National Cancer Institute) in developing (1) biomarkers that could be used to evaluate how drugs work and getting them approved for general use, and (2) tests used to guide treatment selection for the individual patient (i.e., personalized medicine). All patients in our trials gain access to our diagnostic resources and receive treatments that are not otherwise available and could extend their lives or improve their quality of life.

Ensuring Long-term Viability of the PCCTC’s Collaborative Drug Development Paradigm: In 2014, the Coordinating Center established an independent entity, the PCCTC, to secure and expand our enhancements to the clinical trial environment; become financially self-sufficient, as stipulated by the consortium’s previous funding mechanism; and achieve long-term viability. We aim to maintain our viability by making further enhancements to our data management, correlative science, and regulatory programs.

Making a Significant Impact: By implementing an organizational structure that allows interactions among participating sites, trial sponsors (pharmaceutical and biotech companies), and regulatory agencies, the PCCTC Coordinating Center at MSK has created a replicable blueprint that other consortia can use, a tested plan that has the potential to expedite research and new therapies in other scientific fields. The PCCTC has established itself as the nation’s premier prostate cancer clinical trials group and remains poised to make a significant impact on the lives of patients by keeping the drug pipeline primed with promising novel agents.