DoD Prostate Cancer, Prostate Cancer Pathology Resource Network Award

Organization
DOD
Type
DOD
Application Due Date
09-24-2020
Number
W81XWH-20-PCRP-PCPRNA
Brief Description

The FY20 PCRP Prostate Cancer Pathology Resource Network (PCPRN) Award is intended to provide

infrastructure support for the development and maintenance of a prostate cancer biorepository

through a collaborative network across multiple institutions that will facilitate the collection,

processing, annotation, storage, and distribution of high-quality human prostate cancer

biospecimens. A major focus of the Network must be placed on the acquisition and distribution of

specimens in limited supply, such as:

•    Castration-resistant disease, metastatic disease, primary untreated “de novo” metastatic

disease as defined by STAMPEDE or high-risk disease defined by CHAARTED, tumors of the aggressive

variant phenotype

•    Disproportionately affected (African Americans, African-descent, Veterans, etc.) and

underserved (uninsured, rural communities, etc.) populations

•    Active surveillance populations

•    Longitudinal/sequential specimens

The Network must also collect, store, and manage data derived from the distributed biospecimens,

including digital images of the hematoxylin and eosin (H&E)-stained samples and blood-based

germline assessments.

Applications should describe how the development of the Network biorepository will enable the

prostate cancer research community to address the FY20 PCRP Overarching Challenges by utilizing

Network biospecimens. Applications should propose a clearly defined mission that will guide the

proposed Network’s biospecimen collection, distribution, and data collection

cesses.

The Network will consist of three to five Pathology Resource Sites, one of which will also serve as

the Coordinating Center. These organizations will be jointly responsible for developing and

maintaining the biorepository for prostate cancer research. The Coordinating Center and Pathology

Resource Sites should together design the proposed biorepository. It is expected that the

Coordinating Center will provide unique resources that may not be available at the Pathology

Resource Sites and can be leveraged for the biorepository as a whole. Additionally, Pathology

Resource Sites should each possess the ability to derivatize DNA, RNA, and proteins from

biospecimens 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. Both U.S. and international organizations should be

considered for inclusion in applications for this award. The Pathology Resource Sites should be

selected for the individual contributions each can make to the biorepository; the contributions

need not be equal but rather of unique value to the biorepository as a whole. If the contributions

vary significantly among Pathology Resource Sites, variance in the budgets allocated to sites

should be well described in the budget justification.

The PCPRN Coordinating Center, in addition to functioning as a Pathology Resource Site, will serve

as the nexus for Network information and planning, providing administrative, operational, and data

management support to Pathology Resource Sites in implementing Network policies and standard

operating procedures (SOPs). Therefore, the Coordinating Center will have multidisciplinary

expertise and extensive experience in multi-institutional collaborations in prostate cancer

research. Applications from organizations with resources (such as sufficient equipment for

biorepository functions, pathology and histochemistry infrastructure, and informatics and

information infrastructure to support connectivity between the Coordinating Center and Pathology

Resource Sites for data transfer) already in place to support the development of a biorepository

are encouraged. Principal Investigators (PIs) are expected to have experience and expertise in

human biospecimen procurement, annotation, storage, and distribution, and in developing and

operating a biospecimen repository. PIs should have a proven track record in human pathology.

The PCPRN Award mechanism requires a multi-PI partnership between one Coordinating Center PI (who

will also be the Pathology Resource Site PI at the Coordinating Center) and two to four additional

Pathology Resource Site PIs who will be jointly responsible for development of the biospecimen

repository. Each partner in the Network will be recognized as a PI and submit a separate

application. The Coordinating Center PI will be the Initiating PI and will be responsible for the

majority of the administrative tasks associated with application submission. Pathology Resource

Site PIs at organizations other than that of the Coordinating Center will be the Partnering PIs. 

Initiating and Partnering PIs each have different submission requirements, as described in Section

II.D, Application and Submission Information; however, all PIs should contribute significantly to

the preparation of each of the application components. If recommended for funding, each PI will

receive their own award.

The principal areas of responsibility for the Prostate Cancer Pathology Resource Network are as

follows:

•    Biospecimens: The biorepository will collect, process, annotate, store, and distribute high-

ancer biospecimens and matched or unmatched normal tissues andother non-anatomic pathologic samples to include blood, urine, prostatic fluids, and other source

genomic and proteomic material. Prospective collection of high-quality prostate cancer

biospecimens is required; however, the inclusion of previously collected high-quality biospecimens

for distribution by the biorepository is encouraged. The Coordinating Center will be responsible

for developing and maintaining Network SOPs for biospecimen collection methods, post-collection

processing, and quality assurance of specimens.

•    The Network must focus significant attention on the collection and distribution of

biospecimens currently in limited supply for research (e.g., castration-resistant disease,

metastatic disease, primary untreated “de novo” metastatic disease as defined by STAMPEDE and

high-risk disease as defined by CHAARTED, tumors of the aggressive variant phenotype), which will

be identified from an annual survey of the prostate cancer research community. In addition, it is

expected that at least one Pathology Resource Site will enable significant accrual of patient

samples from populations that are disproportionately affected (African Americans, African-descent,

Veterans, etc.) and underserved (uninsured, rural communities, etc.).

•    Clinical Annotation of Biospecimens and Data Quality Assurance: Within the framework of the

data management plan, the Network must establish and maintain common data elements (CDEs) and

standardized language to annotate tissue specimens collected for the biorepository. The extent of

the clinical annotation should include data on (1) patient history and demography; (2)

characterization of individual pathological cases to include grade, Tumor Node Metastasis (TNM)

staging, zonal origin of tumor, biospecimen size, storage conditions, the existence of case-matched

normal biospecimens, and other standard parameters; (3) patient treatment to include adjuvant or

neoadjuvant therapeutic interventions, including attention to interventions resulting from

participation in clinical trials; and (4) outcome such as disease progression, recurrence, and/or

prostate-specific antigen (PSA) levels or other biochemical status. Given the importance of

clinical annotation, the PCPRN must provide for regular updating of annotated data in the

repository. To ensure the quality of the biospecimens and the consistency and accuracy of data in

the repository, the Network is expected to develop quality assurance measures for clinical and

pathological data and data transmission by establishing policies for appropriate quality control

and quality assurance.

•    Informatics and Data Management: It is expected that the Network will develop and maintain 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. The system

should remain current and responsive to the prostate cancer research community so that data can be

both retrieved and deposited into the system. Costs associated with developing the common

informatics system are allowable and, if necessary, should be included in the proposed budget.

PIs must provide a plan to deposit all data generated from the use of biospecimens obtained from

the funded biorepository into a common information grid. Investigators utilizing the Network

biospecimens must agree to share the resulting data after publication and as prescribed by the

Network and in accordance with journal policies. The data sharing plan

sharing the data with the prostate cancer research community through

 

an internet-accessible source administered by the Coordinating Center. In addition, in order to

maximize the impact of the biorepository, protocols and other methods used to derive tests, assays,

and associated data from the biorepository specimens must be available to the entire prostate

cancer research community via an open source system such as public websites.

•    Informed Consent: Applications for the PCPRN Award are expected to demonstrate plans for

establishing and managing procedures to ensure requests for use of biospecimens are in compliance

with the local institutional review boards (IRBs) for the conduct of research and the protection of

human subjects. Assurances should be made for appropriate acquisition of patient-informed consent,

with tiers as appropriate, to include clinicians, surgeons, or other personnel necessary for the

consent process, and disassociation of patient identities from biospecimens. PIs should also

address how informed consent will be handled beyond consent obtained for surgical procedures. This

includes specimens collected during routine medical care that will be used for future research

purposes.

•    Intellectual Property and Material Transfer Agreements: Since the biospecimen repository

will be a collaborative network of institutions, the Network PIs will work together with the

Coordinating Center to resolve potential intellectual and material property issues and remove any

institutional barriers that might interfere with achieving the high levels of cooperation necessary

for the success of the biorepository Network. Applications for the PCPRN Award must provide

documented evidence of institutional commitment to allowing specimens collected at Pathology

Resource Sites to be sent to investigators at non-Network institutions for the purpose of

conducting prostate cancer research.

•    Organizational Structure: The overall organizational structure of the PCPRN is three to five

procurement Pathology Resource Sites, one of which will also serve as the Coordinating Center. The

Coordinating Center organization, in addition to functioning as one of the Pathology Resource

Sites, will serve as the nexus for Network information and planning, providing administrative,

operational, and data management. The Coordinating Center PI will serve as the Scientific Director

of the Network and the Chair of the Steering Committee. In addition to the Coordinating Center PI

and the Pathology Resource Site PIs and collaborators, other key personnel in the Network include:

○    A Coordinating Center Network Director who will be responsible for the overall development

and operation of consortium activities, including daily operations of the Coordinating Center;

○    A Coordinating Center Data Management Specialist who will interact and oversee all

informatics and data management within the Network;

○    A Coordinating Center Data Quality Control Specialist who will be responsible for

implementing established operational procedures to ensure the quality of biospecimens and

biospecimen data across the Network and the shared information grid; and

 

○    Pathology Resource Site Coordinators (one for each Site) who will work with the Coordinating

Center Network Director on Network-wide functions in addition to Pathology Resource Site-specific

functions.

○    A Steering Committee composed of Coordinating Center PI (Chair), Pathology Resource Site PIs

and/or co-PIs, and other personnel with key expertise will assume the role of the governing body

with responsibility for operation of the biorepository Network. This committee will also be

responsible for establishing polices that govern SOPs (in accordance with the National Cancer

Institute’s [NCI’s] “Best Practices for Biospecimen Resources”

[http://biospecimens.cancer.gov/global/pdfs/ NCI_Best_Practices_060507.pdf]). Representatives of

the PCRP, CDMRP, and/or U.S. Army Medical Research and Development Command (USAMRDC) must be

invited to participate as members of the Steering Committee.

○    External Advisory Board: To ensure optimal conduct and oversight of Network activities, the

Network will propose and develop an External Advisory Board (EAB). Applications must include a

description of the proposed EAB members, the role of each member (e.g., scientific, business, or

other type of review), evidence of agreement to serve, and plans for interaction between the EAB

and Network members, which should, at a minimum, include meetings (whether in person or by other

means) no less than twice yearly. Support for this interaction must be included in the proposed

budget. In selecting EAB members, the types of samples to be collected should be considered, as

well as the importance of having external expertise in pathology, biobanking, and current

advancements in biospecimen science.

The Government reserves the right to require augmentation of the EAB membership prior to or during

the award performance period. In addition, representatives of the PCRP, CDMRP, and/or USAMRDC must

be invited to participate in meetings involving the EAB. The Government reserves the right to

direct the location of any in-person meeting.

nt participation should not be included in the proposed budget.