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: PC131984
Award Number: W81XWH-15-2-0018
Funding Mechanism: Clinical Consortium Award - Coordinating Center with a Clinical Research Site
Partnering Awards:
Award Amount: $7,330,349.00
Period of Performance: 6/15/2015 - 6/14/2018


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, MD, Chief of the Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center (MSKCC). 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 concerns of its investigators. This approach has enabled the PCCTC to enroll nearly 4000 men to 127 early-phase trials and critically, advance 10 drugs to Phase III study, two of which, Zytiga and Xtandi, have been approved by the Food and Drug Administration.

Targeting Unmet Needs in Prostate Cancer Clinical Care: MSKCC 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 too risky. The PCCTC has also tasked itself with improving care for patients from disproportionately affected populations. As such, MSKCC and the entire Consortium 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.

Ensuring Long-Term Viability of the PCCTC's Collaborative Drug Development Paradigm: The Coordinating Center has established an independent entity, the Cancer Clinical Trials Consortium, LLC, to secure and expand our enhancements to the clinical trial environment, to become financially self-sufficient as stipulated by the Consortium's previous Clinical Consortium Award, and to achieve long-term viability.

Making a Significant Impact: By implementing an organizational structure that allows for interactions between participating sites, trial sponsors, and regulatory agencies, the PCCTC Coordinating Center at MSKCC 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.