DoD Prostate Cancer, Impact Award from the Department of Defense

• Impact: Research supported by the Impact Award will have the potential for a major, near-term impact in addressing one or more of the FY18 PCRP Overarching Challenges. It is expected that the results of the proposed research will have the potential to transform the clinical management of prostate cancer within 5 years after the end of the award. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly describe the potential impact of the proposed study on the clinical management of prostate cancer and to convey its level of significance. Applications must include a detailed transition plan that articulates the pathway to moving the project’s findings to the next phase of development after successful completion of the award, and how the PI will continue advancing the research towards making a clinical impact, even if clinical impact is not an immediate outcome.

• Research Scope: Proposed projects may include basic, translational, or clinical research, including clinical trials, but must demonstrate clinical relevance. Investigators from a wide spectrum of disciplines, including but not limited to, engineering, bioinformatics, population science, and psycho-oncology, are encouraged to apply, and multidisciplinary projects are encouraged. Only small-scale (i.e., up to and including Phase II or equivalent) clinical trials are allowed. Investigators proposing a clinical trial are highly encouraged to consider leveraging the PCRP-funded Prostate Cancer Clinical Trials Consortium (PCCTC) (http://pcctc.org/) to facilitate the rapid initiation and completion of the trial. Projects that incorporate population science-based approaches are particularly encouraged. Applications must include preliminary data to support feasibility of the study. Any unpublished, preliminary data provided should originate from the laboratory of the PI or a member(s) of the research team.

To maximize the potential for impact, investigators are strongly encouraged to incorporate the following components into their study design where appropriate: authentication of proposed cell lines; statistical rigor of preclinical animal experiments and epidemiological studies; and validation in patient cohorts. As such, the PCRP-funded Prostate Cancer Biorepository Network (PCBN) (http://www.prostatebiorepository.org) and/or the North Carolina – Louisiana Prostate Cancer Project (PCaP) (https://pcap.bioinf.unc.edu) are important resources to consider if retrospectively collected human anatomical substances or correlated data are critical to the proposed studies. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research and that apply state-of-the art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged.

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

The anticipated direct costs budgeted for the entire period of performance for an FY18 PCRP Impact Award will not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Extramural Organizations: An assistance agreement (grant or cooperative agreement) is appropriate when the Federal Government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States, instead of acquiring property or service for the direct benefit and use of the U.S. Government. An assistance agreement can take the form of a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.