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

FAQs: DoD Prostate Cancer Research Program (PCRP) Translational Science Award (FY22)

What is the main purpose of the FY22 PCRP Translational Science Award?

This award is meant to move prostate cancer discoveries beyond the early concept stage and closer to real-world clinical use. The emphasis is on advanced translational work that connects basic science and clinical insight, with results that can support the next concrete development step toward patient impact.

What kind of research is this award trying to support?

The opportunity focuses on later-stage translational studies that are mature enough to credibly advance toward clinical application. The work is expected to be tightly linked to clinical needs and designed to produce decision-ready results that inform what happens next in development.

Is this award intended for brand-new targets or early exploratory mechanistic studies?

No. The award is not intended for initial, exploratory mechanistic work on brand-new targets. It is aimed at transforming promising concepts that already have support and evidence into applications that can move toward clinical use.

How does the program define the translational approach it wants to see?

The solicitation emphasizes bidirectional translation: moving ideas from bench to bedside and from bedside back to bench. Projects should show a clear connection between biological understanding and clinical context, with the goal of accelerating a credible path toward clinical impact.

What are examples of projects that fit this award?

Examples described in the announcement include:

• Advanced preclinical studies that extend animal findings into human-relevant settings using human samples or cohorts
• Late-stage preclinical development activities that position a therapy, diagnostic, or technology for the next step, including preparation activities for an Investigational New Drug (IND) submission
• Correlative studies using biospecimens and data from open, ongoing, or completed clinical trials to refine clinical management or generate new research directions
• Projects that develop or validate clinical trial endpoints

Do applications need preliminary data?

Yes. Applications are expected to include preliminary data that supports both the scientific rationale and the feasibility of the approach. The solicitation also strongly encourages additional preliminary work that helps establish clinical relevance.

What will reviewers look for in study design and rigor?

Reviewers will look for designs that can generate interpretable, decision-ready results. The announcement emphasizes statistical rigor and thoughtful sample-size planning, including justification that the proposed sample sizes are appropriate to meet the study objectives.

Do applicants need to show access to specimens, datasets, or patient populations?

Yes. Beyond proposing a compelling translational question, applicants are expected to demonstrate practical access to the needed resources, such as specimens, datasets, or patient populations, at the scale required to execute the work and reach strong conclusions.

Is a transition plan required?

Yes. Proposals must include a detailed transition plan describing what happens after the award ends if the project is successful. This plan should lay out the next development milestone and how the team will advance the work into the next phase (for example, additional preclinical development, regulatory preparation, or positioning for a future clinical trial).

Does the transition plan need to address clinical impact even if it is not immediate?

Yes. The program expects applicants to treat the project as part of a credible development pathway. The transition plan should explain how the investigators intend to keep pushing toward clinical impact even if that impact is not fully realized within the period of performance.

Are human subjects studies allowed under this award?

Yes. Human subjects research is allowed, including studies involving human anatomical substances and certain other human-related research activities, provided all required reviews and approvals are obtained.

Are clinical trials allowed?

No. Clinical trials are not permitted. The solicitation draws a clear line against studies that prospectively assign participants to interventions to evaluate outcomes (i.e., studies meeting the standard definition of a clinical trial).

Are correlative studies connected to clinical trials allowed?

Yes. Correlative studies that leverage biospecimens and data from open, ongoing, or completed clinical trials are particularly encouraged, as long as they are appropriately reviewed and determined to be no greater than minimal risk by the responsible Institutional Review Board (IRB) and by the US Army Medical Research and Development Command human protections offices.

What human research oversight is required beyond local IRB review?

For projects involving human anatomical substances, human subjects, or cadavers, an additional Department of Defense review through the Human Research Protection Office (HRPO) is required on top of local IRB review.

How long should teams plan for DoD HRPO review?

Applicants are advised to plan for an approval timeline that can take up to about three months once complete materials are submitted.

What is required for multi-site human subjects studies?

Multi-site studies must include a written plan describing how a single IRB (sIRB) arrangement will be handled, including identification of the lead institution responsible for the master protocol and consent.

Are animal studies allowed, and are there extra DoD reviews?

Animal work is permitted, but it must undergo an additional Department of Defense review through ACURO (in addition to local IACUC review). The announcement warns applicants to budget time for this review process, which can take several months.

What best practices does the solicitation emphasize for preclinical reproducibility?

The solicitation highlights reproducibility and strong study design, including practices such as randomization, blinding, sample-size estimation, and transparent data handling. It also points to reporting frameworks such as ARRIVE 2.0.

Does the program encourage team science or multiple PIs?

Yes. The announcement includes a Partnering PI option designed for two principal investigators with distinct and meaningful contributions, and it particularly encourages collaborations that bridge basic and clinical expertise.

How does the Partnering PI structure work?

One PI serves as the Initiating PI and is responsible for most submission administration. 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.

What type of funding mechanism is used for these awards?

Awards are issued as assistance agreements, made either as grants or cooperative agreements depending on how much substantial involvement the DoD anticipates having during performance.

What is the maximum direct cost amount allowed?

The direct cost cap for the full period of performance is up to $900,000.

How many awards and how much total funding did the program plan for?

The program planned to allocate roughly $7.2 million in total to make about five awards.

When were awards expected to be made?

Awards were expected no later than September 30, 2023, with funding contingent on federal fund availability and the outcome of scientific and programmatic review.

Who is eligible to apply?

Eligible applicants are described as unrestricted, meaning a wide range of organizations can apply, subject to the specific eligibility clarifications in the full announcement.

Does the research need to be relevant to military populations?

Yes. The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public.

Are collaborations with military or VA institutions encouraged?

Yes. The DoD strongly encourages collaborations between military or VA institutions and non-military partners to leverage unique populations, infrastructure, and clinical insight.

Does the award have an emphasis on addressing specific program challenges?

Yes. The award is aimed at advancing applications that could ultimately address one or more of the FY22 PCRP Overarching Challenges, with a clear focus on patient impact.

What is the common theme across the different eligible project types?

The common thread is maturity and readiness for translation: projects should be far enough along to support a realistic next step toward clinical application, rather than primarily generating early biological understanding.