DoD Prostate Cancer Biospecimen Resource Site Award | Apply Online

Frequently Asked Questions (FAQs)

What is the DoD Prostate Cancer Biospecimen Resource Site Award (PCBRSA)?

The PCBRSA is a FY14 Department of Defense funding opportunity from the Department of the Army (USAMRAA) under the Congressionally Directed Medical Research Programs (CDMRP) Prostate Cancer Research Program (PCRP). It supports the addition of new biorepository Resource Sites to expand a DoD-supported national effort called the Prostate Cancer Biorepository Network (PCBN).

What is the main purpose of this award?

The award is designed to strengthen and expand the PCBN by adding new Resource Sites that can provide high-quality, well-annotated human prostate cancer biospecimens and associated clinical and pathology data to the broader prostate cancer research community.

Is this funding mechanism a grant or something else?

In FY14, the PCBRSA is offered for the first time as a cooperative agreement, emphasizing active collaboration and participation in network governance, shared informatics, and standardized procedures.

What is the Prostate Cancer Biorepository Network (PCBN)?

The PCBN is a DoD-supported national biorepository network that provides researchers access to human prostate cancer biospecimens and associated clinical and pathology data. It was previously built through the Prostate Cancer Pathology Resource Network awards (FY09 and FY13).

Which institutions were part of the PCBN as of FY13?

As of FY13, the PCBN included four major institutions: Johns Hopkins University (serving as the Coordinating Center and also a Resource Site), New York University, the University of Washington, and Memorial Sloan Kettering Cancer Center (as additional Resource Sites).

What types of biospecimens does the program prioritize?

While the program emphasizes specimens across the full clinical spectrum of prostate cancer, it places particular priority on specimens that are unique, rare, or otherwise in limited supply, especially those that help answer difficult research questions not easily addressed with typical collections.

What are examples of "limited-supply" or high-priority specimens mentioned in the opportunity?

Examples include: specimens from disproportionately affected populations; biopsies of metastatic lesions (especially when matched to the patient’s primary tumor tissue); matched pre- and post-neoadjuvant treatment tissue and/or matched serum or plasma; and serial collections of tissue or body fluids such as serum, plasma, or urine.

Which clinical timepoints are emphasized for serial collections?

Serial sampling is especially emphasized at key clinical transitions and timepoints, including: before and after androgen deprivation therapy or metastatic therapy; before and after development of castration-resistant status; and longitudinal sampling in high-risk disease or active surveillance cohorts (including baseline and progression events such as Gleason upgrading or increased tumor volume on biopsy).

Do applicants need to show how their collections complement what PCBN already has?

Yes. Applicants are encouraged to review what specimens the PCBN already offers and clearly explain how their proposed collections would fill gaps and measurably enhance the network’s value.

What is a "Resource Site" in the context of this program?

A Resource Site is an active biorepository node within the PCBN that prospectively collects, processes, annotates, stores, and distributes human prostate cancer biospecimens at consistently high quality, in alignment with network policies and standardized procedures.

Is prospective biospecimen collection required?

Yes. Funded Resource Sites are expected to be capable of prospectively collecting biospecimens. The inclusion of previously collected, high-quality specimens for distribution is also encouraged.

What regulatory requirements must a Resource Site meet?

Resource Sites must have appropriate regulatory oversight, including Institutional Review Board (IRB) approval and informed consent that permits broad sharing of specimens and data.

What technical capabilities are expected for specimen processing and downstream research use?

Sites are expected to support modern translational research needs, including the ability to derive DNA, RNA, and proteins and to use standard and advanced approaches such as laser capture microdissection and tissue microarrays.

What quality assurance expectations are described in the opportunity?

Applications must describe concrete quality assurance approaches so the network can rely on consistency, integrity, and research-grade suitability of the distributed materials. This includes quality control for both biospecimens and associated data capture/transmission.

What clinical and pathology annotation is required?

Resource Sites must contribute robust clinical and pathology annotation using common data elements and standardized language harmonized across the network, supported by established quality assurance procedures for data capture and transmission.

What are the minimum clinical data elements expected to be included with specimens?

At a minimum, annotation is expected to include basic demographics (such as age and race) and clinical characterization such as clinical stage, PSA levels, diagnosis timing, prior cancer history, treatments and dates, and outcomes (recurrence, metastasis, or death) with time-to-event information.

What pathology and processing details are expected to be annotated?

Expected annotation includes pathology and processing details such as Gleason grades, surgical pathology information, collection methods, and storage conditions.

Is a uropathologist required to be involved?

Yes. Each site must ensure active participation of an experienced uropathologist to support accuracy and consistency in pathology interpretation.

What informatics requirements are associated with participating in the PCBN?

The PCBN uses a common informatics system to manage inventory and associated data while maintaining security and data integrity. Resource Sites are expected to fully participate in the shared data management plan, including the ability to transmit data in flexible formats and staffing personnel with informatics and/or database expertise.

Are costs for informatics participation allowable in the budget?

Yes. Costs tied to developing or participating in the shared informatics environment are described as allowable and should be planned for explicitly.

How does the program address intellectual property (IP) and material transfer issues?

Resource Sites must collaborate with the Coordinating Center and other network members to resolve IP and material transfer issues and eliminate institutional barriers that could interfere with distribution.

Is institutional commitment to sharing specimens outside the network required?

Yes. A key application requirement is documented evidence of institutional commitment to allow specimens collected at the site to be shared with investigators outside the network.

How is the PCBN governed?

Network direction is provided by a Steering Committee chaired by the Coordinating Center principal investigator and including Resource Site leadership, key coordinating staff (such as the Network Manager and data specialists), at least one prostate cancer survivor, and other experts as needed.

What types of policies and procedures does the network maintain?

The Steering Committee sets and maintains network policies and SOPs aligned with NCI Best Practices for Biospecimen Resources. These cover topics such as quality control, collection and processing, annotation standards, distribution rules and prioritization, ethical and legal compliance, and cost/fee policies for handling and shipping specimens.

What is the External Advisory Board (EAB) and how often does it meet?

The PCBN convenes an External Advisory Board twice per year for oversight and guidance, and all Resource Site principal investigators are required to participate in every EAB meeting.

Is a specific staff role required at each Resource Site?

Yes. Each applicant site must designate a Resource Site Coordinator to interface with the Coordinating Center’s Network Manager on network-wide responsibilities and local operations.

What are the annual performance expectations for biospecimen contributions?

Each funded Resource Site is accountable for contributing biospecimens from at least 50 patients per year, with an emphasis on limited-supply specimens and the required accompanying clinical and pathology data.

What deliverables and operational requirements are emphasized?

Sites must document specimen and data quality control, harmonize their SOPs with existing PCBN procedures, complete successful data transfers to the Coordinating Center, and submit required reports on time.

What happens if a funded Resource Site does not meet performance metrics?

Failure to meet required metrics can lead to funding restrictions, reflecting the program’s focus on steady, measurable biospecimen and data output for the research community.

What is the estimated total funding amount and number of expected awards?

The listing indicates an estimated total funding amount of $1.3 million and an expectation of two awards.

Which federal program category is associated with this opportunity?

This is described as a discretionary DoD funding opportunity under CFDA 12.420 (Military Medical Research and Development).

Who is eligible to apply based on the listing?

Eligibility is described as unrestricted (open to any entity type, subject to clarifications in the full announcement). Both US and international organizations are encouraged to apply.

When was the opportunity posted and what was the application deadline?

The opportunity was posted on May 30, 2014, and the application closing date was October 29, 2014.