DoD Prostate Cancer, Translational Science Award | W81XWH 19 PCRP TSA

Opportunity Information: Apply for W81XWH 19 PCRP TSA

The DoD Prostate Cancer Research Program (PCRP) Translational Science Award (FY19) is designed to push strong, clinically relevant prostate cancer ideas further down the development path so they can realistically reach patient care. The program frames "translational research" as work that deliberately links basic science with clinical observations, where the original insight could come from a lab discovery, population level data, or direct experience treating patients. A central expectation is that the project will not just add another incremental data point, but instead deliver a meaningful step forward that sets up a clear next stage toward clinical use. In practical terms, applicants are expected to show how information will move in both directions between the laboratory and the clinic, not simply in a one-way "bench to bedside" line.

A key feature of this opportunity is the required transition plan. Every application must spell out, in detail, what happens after the award ends: how the results will be advanced into the next phase of development, what the logical follow-on activities are, and how the principal investigator will continue driving the work toward real clinical impact even if a direct patient impact is not achieved during the award itself. This emphasis is meant to ensure that funded projects are positioned to keep moving rather than stalling after proof-of-concept.

The mechanism supports a broad range of translational work as long as it is clearly tied to clinical relevance in prostate cancer. Examples specifically highlighted include: translating in vitro and/or animal findings into applications using human samples or human cohorts; late stage preclinical development aimed at preparing for a clinical trial (including activities consistent with moving toward an Investigational New Drug submission); and correlative studies linked to an open, ongoing, or completed clinical trial, including projects that develop or validate endpoints that can be used in clinical trials. While the scope can include basic, translational, population science, and some forms of clinical research, the common requirement is that the work must connect convincingly to patient-facing needs and decision-making.

Feasibility is not optional in this competition. Applicants must provide preliminary data to justify that the hypotheses and approach are workable and that the team can execute the proposed plan. For projects that depend on retrospectively collected human specimens or associated data, the announcement strongly encourages investigators to leverage established resources funded by the PCRP, especially the Prostate Cancer Biorepository Network (PCBN) and the North Carolina to Louisiana Prostate Cancer Project (PCaP). Using these kinds of existing collections can strengthen feasibility, accelerate timelines, and support access to well-annotated samples.

The opportunity also aligns with broader federal interest in improving outcomes for advanced and recurrent cancers. The announcement points applicants to the Congressionally mandated Metastatic Cancer Task Force recommendations and encourages proposals that speak to those priorities, as long as the work still fits the PCRP focus and the specific limits of this award. Across the board, proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the broader American public, reflecting the DoD mission and the program's public health intent.

From a funding and competitiveness standpoint, the award provides up to $750,000 in direct costs for the entire performance period. The program expected to allocate roughly $12 million total to support around 10 awards, making it a relatively selective mechanism aimed at well-justified, high-impact translational projects. The sponsor notes that awards depend on federal fund availability and on scientific and programmatic review outcomes. Awards were expected to be made by September 30, 2020, and the underlying FY19 funds were anticipated to remain available for obligation only within federal time limits, with FY19 funds expiring for use on September 30, 2025.

Administratively, awards are issued as assistance agreements, either a grant or a cooperative agreement. Which one applies depends on how much involvement the DoD expects to have during project performance. If the agency anticipates no substantial involvement, it will use a grant; if substantial involvement is expected (such as active collaboration, participation, or intervention), it will use a cooperative agreement, and the award will specify what that involvement looks like. The start date and final award type are determined during negotiation.

Human subjects research is allowed under this opportunity, but clinical trials are not permitted as the direct activity funded by this award. The program uses a specific definition of a clinical trial: a study where human subjects are prospectively assigned to one or more interventions to evaluate effects on health-related outcomes. Applicants can still be involved in clinical trials as part of the broader project ecosystem, but the clinical trial costs must be supported by other funding sources. What the DoD especially encourages here are correlative studies tied to existing clinical trials, provided they are considered no greater than minimal risk by the relevant Institutional Review Board and the DoD human research protection office.

If a project uses human anatomical substances, human subjects, or human cadavers, it must go through DoD-specific regulatory oversight in addition to local ethics review. The USAMRMC Office of Research Protections, Human Research Protection Office (HRPO), must review and approve the work before research begins. Local IRB approval is not required at submission, but HRPO approval is mandatory before implementation, and investigators are advised to build in at least 2 to 3 months for HRPO review, with potentially longer timelines for international studies. The announcement also cautions applicants to keep protocols tightly scoped to the DoD-funded work when possible, because submitting broader protocols that include non-DoD activities can trigger wider HRPO review and can impose DoD requirements on the entire protocol, including non-DoD funded components. For studies that recruit human subjects, the application must include quarterly enrollment targets across all sites in the statement of work, and awardees should expect recruitment milestones to be negotiated and tracked, with continued support tied to meeting agreed progress.

Projects that rely on Department of Defense or Department of Veterans Affairs populations, resources, space, equipment, or databases must document access plans at submission and, in many cases, provide letters of support from the appropriate authority. For DoD access, the letter should be signed by the lowest-ranking individual with approval authority. For VA access, confirmation typically comes from the VA Facility Director or a designee such as the Associate Chief of Staff for Research and Development or a Clinical Service Chief. The announcement also highlights a common practical constraint: certain DoD or VA resources may be restricted and only accessible through collaboration with an eligible DoD or VA investigator who has a meaningful role in the research. If access cannot be confirmed, the government may withdraw or revoke funding until access is adequately demonstrated.

Animal research is also allowed, but it carries an additional DoD review layer. Beyond local Institutional Animal Care and Use Committee requirements, all DoD-funded animal work must be reviewed and approved by the USAMRMC Animal Care and Use Review Office (ACURO) before animal studies begin, including approval of amendments for ongoing projects. As with human subjects review, IACUC approval is not required at submission, but selected applicants will need to provide the animal use protocol, proof of IACUC approval, and a required animal use appendix, and they should plan for at least 2 to 3 months for ACURO review.

In short, this Translational Science Award is aimed at well-supported prostate cancer projects that can credibly bridge discovery and patient impact, demonstrate clear clinical relevance, and lay out a realistic, detailed pathway to the next development stage. It offers substantial but capped direct-cost support, favors projects with strong preliminary evidence and a concrete transition strategy, and requires applicants to plan carefully for DoD-specific compliance steps when human participants, human specimens, VA/DoD resources, or animals are involved.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Prostate Cancer, Translational Science Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on May 03, 2019.
• Applicants must submit their applications by Jul 18, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 10 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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