DoD Prostate Cancer Biospecimen Resource Site Award
The PCRP Prostate Cancer Biospecimen Resource Site (PCBRSA) Award mechanism is being offered for the first time in FY14. This award mechanism is designed as an opportunity to expand upon the Prostate Cancer Pathology Resource Network Award, offered in FY09 and FY13. Background: The FY13 PCRP Prostate Cancer Pathology Resource Network Award is currently supporting four organizations that together form the Prostate Cancer Biorepository Network (PCBN) (http://www.prostatebiorepository.org/). These organizations include Johns Hopkins University, designated as both the Coordinating Center and a Resource Site, and New York University, University of Washington, and Memorial Sloan-Kettering Cancer Center as three additional Resource Sites. The PCRP provides infrastructure support to these awardees for the development and maintenance of a prostate cancer biorepository that will facilitate the collection, processing, annotation, storage, and distribution of high-quality human prostate cancer biospecimens to be distributed to the prostate cancer research community. Biospecimens, which include tissues, blood, urine, prostatic fluids, and other source genomic and proteomic material, are collected from the broad spectrum of prostate cancer clinical stages, but major emphasis is placed on the acquisition and distribution of specimens in limited supply (e.g., castration-resistant disease, metastatic disease, tumors of the neuroendocrine phenotype, disproportionately affected populations, active surveillance populations, longitudinal specimens). The PCBN is also responsible for the collection, storage, and management of data derived from distributed biospecimens. All PCBN organizations are jointly responsible for maintaining and enhancing the activities of the biorepository. The PCBN Coordinating Center, in addition to functioning as a Resource Site, serves as the nexus for information and planning, providing administrative, operational, and data management, and providing support to Resource Sites in implementing PCBN policies and standard operating procedures (SOPs). Additional responsibilities of the PCBN Coordinating Center are described in the FY13 Prostate Cancer Pathology Resource Network Award Program Announcement found at http://cdmrp.army.mil/funding/pa/13pcrppcprna_pa.pdf. FY14 Funding Opportunity: The intent of the PCBRSA is to expand the PCBN by adding Resource Sites that will enhance the biorepositoryÂ’s utility to prostate cancer researchers through the provision of biospecimens that are unique and/or in limited supply. Both U.S. and international organizations are encouraged to apply to this Program Announcement/Funding Opportunity. Biospecimens encouraged for the current funding opportunity include, but are not limited to: • Samples from disproportionately affected populations • Biopsies of metastatic lesions (particularly those with matched primary tissue) • Pre- and post-neoadjuvant matched tissue samples and/or matched serum/plasma samples • Serial samples of tissue or body fluids (e.g., serum, plasma, urine) that may include: ○ pre- and post-androgen deprivation therapy or metastatic therapy ○ pre- and post-castrate resistant status ○ high-risk prostate cancer (pT3 or prostatectomy Gleason score ≥ 4+3), both pre- prostatectomy and at long-term (3+ years recurrence-free or time of recurrence or metastasis) ○ active surveillance baseline and at time of histopathologic progression (i.e., biopsy Gleason upgrading or increase in biopsy tumor volume) Principal Investigators applying to this award mechanism are also encouraged to review the current specimens offered by the PCBN described at http://www.prostatebiorepository.org/specimens). Applications for the PCBRSA should describe how the organizationÂ’s contributions to the PCBN will enhance its ability to enable the prostate cancer research community to address the PCRP overarching challenges and PCRP focus areas. The principal areas of responsibility for each Resource Site are as follows: 1. Biospecimens: The biorepository collects, processes, annotates, stores, and distributes high-quality human prostate cancer biospecimens. Prospective collection of high-quality prostate cancer biospecimens is required of each Resource Site; however, the inclusion of previously collected high-quality biospecimens for distribution is encouraged. Resource Sites must ensure Institutional Review Board (IRB) approval and informed consent to share samples and data. In addition, each Resource Site should possess the ability to derivatize DNA, RNA, and proteins and utilize both standard and state-of-the-art technologies (e.g., laser capture microdissection, tissue microarrays) to provide the necessary biospecimen processing for a large range of prostate cancer research studies. Applications should include descriptions of how the quality of biospecimens collected and distributed will be assured. The Coordinating Center is responsible for developing and maintaining SOPs for biospecimen collection methods and post-collection processing for PCBN members and ultimately for sharing the SOPs with the wider prostate cancer research community. 2. Clinical Annotation of Biospecimens and Data Quality Assurance: In addition to the importance of high-quality tissue specimens, annotation of the specimens is critical to the success of research studies to be conducted with samples obtained from the biorepository. Resource Sites must, to every extent possible, adhere to the common data elements (CDEs), standardized tissue annotation language, and quality assurance measures for clinical and pathological data and data transmission jointly established by the PCBN members. The extent of the clinical and pathologic annotation should include, at a minimum, (1) basic demographics (e.g., age, race); (2) clinical characterization (e.g., history of prior cancer, clinical stage, prostate specific antigen (PSA) levels, date or year of diagnosis, type and date of any treatment, recurrence/metastasis/death outcomes and time to event data); pathology data (e.g., biopsy primary and secondary Gleason grade, surgical pathology); and processing data (e.g., methods of collection, storage conditions). Each Resource Site must ensure the active participation of an experienced uropathologist. 3. Information and Data Management: The PCBN maintains a comprehensive data management plan that includes a common informatics system to manage the biorepository resources and provide for ongoing data transfer, security, and integrity. All Resource Sites are expected to fully participate in and contribute to the data management plan, which will require: • the ability to share data in a flexible format and • the participation of personnel knowledgeable in informatics and/or database development. Costs associated with developing and/or participating in the common informatics system are allowable and should be included in the proposed budget. 4. Intellectual and Material Transfer Agreements: Since the biospecimen repository is a collaborative network between institutions, Resource Sites will work together with the Coordinating Center to resolve potential intellectual and material property issues and remove institutional barriers that might interfere with achieving the high levels of cooperation necessary for the success of the biorepository. Applications for the PCBRSA must provide documented evidence of institutional commitment to allowing specimens collected at Resource Sites to be sent to investigators at non-Network institutions for the purpose of conducting prostate cancer research. 5. Organizational Structure: Overall direction and governance of the PCBN is provided by the Steering Committee, which is composed of the Coordinating Center PI (Chair), the Resource Site PIs and/or co-PIs, the Coordinating Center key personnel (i.e., Network Manager, Data Management Specialist, Data Quality Control Specialist), at least one prostate cancer survivor, and other personnel with key expertise. This committee is also responsible for establishing polices that govern SOPs (in accordance with NCI “Best Practices for Biospecimen Resources” (http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf) to include SOPs for quality control, specimen collection, processing, annotation, distribution, legal and ethical regulatory issues, policies for prioritization of specimen distribution, and fees and other costs to investigators for processing, handling, and shipping requests for samples. The Steering Committee coordinates the development of additional committees as necessary. To ensure optimal conduct and oversight of activities, the PCBN convenes an External Advisory Board (EAB) twice yearly. All Resource Site PIs are required to participate in every EAB meeting. Each Resource Site application must name a Resource Site Coordinator, who will work with the Coordinating Center Network Manager on Network-wide functions in addition to Site-specific functions. Overall, the Coordinating Center is responsible for the establishment and management of a communications plan and an ongoing communications system to maintain optimal operation of all Network components. 6. Performance Metrics: Each PCBRSA recipient will be accountable to the following performance metrics, which if not met may result in funding restrictions: • Contribution of biospecimens from a minimum of 50 patients per year, focusing on samples in limited supply and including appropriate clinical and pathology data • Documentation of specimen and data quality control • Harmonization of SOPs with existing PCBN SOPs • Successful data transfer to the PCBN Coordinating Center • Submission of reports in a timely manner
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
