Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Jennifer Shankle Grantor

Description:

The FY24 PCRP Early Investigator Research Award supports prostate cancer-focused research opportunities for individuals in the early stages of their careers under the guidance of one or more designated mentors. This opportunity allows early-career investigators to develop a research project, investigate a problem or question in prostate cancer research, and further their intellectual development as prostate cancer researchers of the future. All application components for the FY24 PCRP Early Investigator Research Award are to be written by the Principal Investigator (PI), with appropriate direction from the mentor(s).

Key elements of this award mechanism are as follows:

• Principal Investigator: The postdoctoral investigator is considered the PI of the application and must exhibit strong potential for and commitment to pursuing a career as an investigator at the forefront of prostate cancer research; however, the PI is not required to have previous prostate cancer research experience. The PI must have 3 years or less of postdoctoral research experience (excluding clinical residency or clinical fellowship training) as of March 31, 2025. The PCRP strongly encourages applications from PIs who demonstrate a commitment to pursuing a career focused on prostate cancer health disparity research.

• Mentor(s): Applications must include at least one mentor appropriate to the proposed research project who has experience in prostate cancer research and mentoring as demonstrated by a record of active funding, recent publications, and successful mentorship. The primary mentor can be a junior faculty member, in which case the PI is encouraged to include a secondary mentor with a more robust track record in prostate cancer research and mentorship. Applications that focus on prostate cancer health disparity should include at least one mentor with experience in prostate cancer health disparity research. The selected mentor(s) should also demonstrate a clear commitment to the development of the PI toward independence as a prostate cancer researcher.

• Research Approach: Proposed research ideas are required to address one or more of the FY24 PCRP Overarching Challenges. Projects that specifically address the FY24 PCRP Overarching Challenge to advance health equity and reduce disparities in prostate cancer are strongly encouraged. The scientific rationale and experimental methodology should demonstrate in-depth analysis of the research problem presented. The feasibility of the research design and methods should be well defined, and a clear plan should be articulated as to how the proposed goals of the project can be achieved. Inclusion of preliminary data relevant to prostate cancer and the proposed project is encouraged but not required. Any preliminary data provided should be from the PI, mentor(s), or member(s) of the collaborating team. Additionally, required resources should be identified and supported through documentation. Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this funding opportunity.

• Researcher Development Plan: The PI must outline an individualized, prostate cancer-focused researcher development plan, which should include a clearly articulated strategy for acquiring the necessary skills, competence, and expertise that will enable the PI to successfully complete the proposed research project and foster the PI’s development as an independent prostate cancer researcher. An environment appropriate to the proposed mentoring and research project must be clearly described, although any deficiencies of resources and/or mentorship at the PI’s institution can be mitigated through collaboration(s) with other institutions. If the PI will be utilizing resources at another institution to successfully complete the proposed project, then the PI is strongly encouraged to designate a co-mentor at the collaborating institution.

Investigators are strongly encouraged to incorporate the following components into their study design, where appropriate, in order to maximize the potential impact of the proposed research project: authentication of proposed cell lines; statistical rigor of preclinical animal experiments; and incorporation of experiments to assess clinical relevance and translatability of findings. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research and apply state-of-the-art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. Investigators are highly encouraged to provide a letter of support indicating access to and the availability of any resources required to support the study.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 PCRP priorities.

Innovative research involving nuclear medicine and related techniques to support early diagnosis, more-effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.

Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (http://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.

Clinical trials are not allowed. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.

(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

(3) Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.

The funding instrument for awards made under the program announcement will be grants (31 USC 6304).

The anticipated direct costs budgeted for the entire period of performance for an FY24 PCRP Early Investigator Research Award should not exceed $300,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $6.24M to fund approximately 13 Early Investigator Research Award applications. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org