DoD Prostate Cancer, Translational Science Award | W81XWH 22 PCRP TSA

Opportunity Information: Apply for W81XWH 22 PCRP TSA

The DoD Prostate Cancer Research Program (PCRP) Translational Science Award (FY22) is designed to push prostate cancer discoveries past the early concept stage and toward real-world clinical use. The core emphasis is on advanced translational work that tightly connects basic science with clinical insight, with the expectation that ideas can move in both directions (bench to bedside and bedside to bench). The program is explicitly aimed at transforming promising, already-supported concepts into applications that could ultimately address one or more of the FY22 PCRP Overarching Challenges, with a clear focus on impact for patients.

This award supports a fairly broad range of later-stage translational studies, but it is not meant for initial, exploratory mechanistic work on brand-new targets. Examples of the kinds of projects the solicitation is looking for include advanced preclinical studies that extend animal findings into human-relevant settings using human samples or cohorts; late-stage preclinical development work that positions a therapy, diagnostic, or technology for the next step (including activities that prepare for an Investigational New Drug submission); correlative studies that leverage biospecimens and data from open, ongoing, or completed clinical trials to refine clinical management or open up new research directions; and projects that develop or validate clinical trial endpoints. Across these categories, the common thread is that the work should be mature enough to credibly move toward clinical application, rather than simply generating early biological understanding.

A key expectation is that applicants bring preliminary data that supports both the scientific rationale and the feasibility of the approach. While the solicitation requires preliminary evidence on rationale and feasibility, it also strongly encourages additional preliminary work that helps establish clinical relevance. Reviewers will be looking for study designs that can produce interpretable, decision-ready results, which includes thoughtful attention to statistical rigor and sample size. Applicants are expected to justify that their sample sizes are appropriate to meet study objectives and to demonstrate practical access to the needed resources, specimens, datasets, or patient populations. In other words, it is not enough to propose an interesting translational question; the application needs to show it can actually be executed at the proposed scale and yield conclusions strong enough to support the next translational step.

Because the point of translational science is forward movement, proposals must include a detailed transition plan. This plan is meant to spell out what happens after the award ends if the project is successful: what the next development milestone is, how the team will advance the findings into the next phase (for example, additional preclinical development, regulatory preparation, or positioning for a future clinical trial), and how the investigators intend to keep pushing toward clinical impact even if that impact is not immediate within the period of performance. The program is effectively asking applicants to treat the work as part of a credible development pathway rather than a standalone research study.

Human subjects research is allowed under this opportunity, but clinical trials are not. The solicitation draws a bright line: studies that prospectively assign participants to interventions to evaluate outcomes (the standard definition of a clinical trial) are not permitted. That said, correlative studies tied to an existing clinical trial are particularly encouraged, as long as they are reviewed appropriately and deemed no greater than minimal risk by the responsible Institutional Review Board and by the US Army Medical Research and Development Command human protections offices. For projects involving human anatomical substances, human subjects, or cadavers, there is an additional Department of Defense review requirement through the Human Research Protection Office (HRPO) that sits on top of local IRB review, and applicants are advised to plan for an approval timeline that can take up to about three months once complete materials are submitted. Multi-site studies also need a written plan describing how a single IRB arrangement will be handled, including identification of the lead institution responsible for the master protocol and consent.

The announcement also encourages team science through a Partnering PI option, which is structured for two principal investigators with distinct and meaningful contributions. One PI serves as the Initiating PI and handles most submission administration, while the Partnering PI is expected to contribute substantively to the scientific development and required application components such as the project narrative and statement of work. If selected, each PI is named on an individual award within the recipient organization, reinforcing the expectation that both investigators are true drivers of the work. Collaborations that bridge basic and clinical expertise are especially encouraged, reflecting the program goal of accelerating translation through complementary skill sets.

From an administrative and funding standpoint, awards are issued as assistance agreements, meaning they will be made either as grants or cooperative agreements depending on how much substantial involvement the DoD anticipates having during performance. The direct cost cap for the full period of performance is up to $900,000. The program planned to allocate roughly $7.2 million total to make about five awards, with awards expected no later than September 30, 2023, and with funding contingent on federal fund availability and the results of scientific and programmatic review. Eligible applicants are listed as unrestricted, meaning a wide range of organizations can apply, subject to the specific eligibility clarifications in the full announcement.

Several additional compliance and rigor expectations are emphasized. If the work involves animals, it must undergo an additional DoD review through ACURO (in addition to local IACUC), and applicants are warned to budget time for that review process (often several months). The solicitation highlights reproducibility and strong study design for preclinical work, referencing widely recognized best practices such as randomization, blinding, sample-size estimation, and transparent data handling, and it points applicants to reporting frameworks like ARRIVE 2.0. Finally, the proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public, and the DoD strongly encourages collaborations between military or VA institutions and non-military partners to leverage unique populations, infrastructure, and clinical insight.

• 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 Apr 04, 2022.
• Applicants must submit their applications by Aug 25, 2022. (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 5 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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