DoD Prostate Cancer Transformative Impact Award

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The PCRP Transformative Impact Award mechanism was first offered in FY12. Since then, 10 Transformative Impact Award applications have been received, and 3 have been recommended for funding. The Transformative Impact Award supports prostate cancer research with near-term clinical relevance that will transform and revolutionize the clinical management of prostate cancer and make a major contribution to the elimination of death from prostate cancer and enhancing the well-being of men experiencing the impact of the disease. For the purpose of this award, clinical management of prostate cancer includes the wide spectrum of screening, detection, diagnosis, prognosis, and/or treatment. Although research that is deemed transformative must contend with potential risks, the proposed project(s) must be supported by thorough review of the literature, a sound rationale, and a well-designed research strategy. Applications must include substantive preliminary data to support the rationale and feasibility of the study. The critical components of this award mechanism are: Research Scope: Since the intent of this award is to achieve near-term clinical impact for patients, the scope of the research effort is expected to include translational research, clinical research, and/or clinical trials. All projects submitted to the Transformative Impact Award mechanism must address one of the PCRP overarching challenges and are expected to address at least one of the PCRP focus areas. Transformative Impact: Projects funded by this award will have a near-term, revolutionary impact on the clinical management of prostate cancer. It is the responsibility of the Principal Investigator (PI) to clearly and sufficiently describe how the proposed project(s) will transform prostate cancer clinical management in the near term. Implementation Plan: The project(s) must be supported by a detailed plan that identifies critical milestones, outlines the knowledge, expertise, and technical innovations that the investigative team will utilize to achieve the milestones and explains how the outcomes of the project(s) will be translated to patients. The application must include information demonstrating accessibility and availability of human subjects and/or human anatomical samples, substances, and/or data necessary for the study so that the project(s) can commence immediately after an award is made. PIs whose study design(s) require human anatomical substances are encouraged to collaborate with personnel affiliated with established prostate cancer biorepositories (e.g., Prostate Cancer Biorepository Network [PCBN] [http://www.prostatebiorepository.org] and/or the North Carolina – Louisiana Prostate Cancer Project [PCaP] [http://www.ncla-pcap.org]). A robust statistical plan and statistical expertise should be included where appropriate in proposed investigation(s). Research Team: It is expected that the proposed research team will include an exceptionally skilled group of individuals (e.g., scientists, clinicians, consumer advocates, etc.) well positioned to achieve the goals, with leadership from multiple collaborators. The PI(s) should possess a track record of success in leading large, focused projects with clinical impact. The PI(s) also should demonstrate a strong commitment to the project and to the research team, and develop a communications plan that fosters consistent and intensive interactions by all team members to accelerate translation of the project’s outcomes to patients and/or for clinical use. The inclusion of scientific advisors, external to the conduct of the research, is encouraged. The PCRP Science Officer assigned to any resulting award must be invited to participate in periodic research team meetings. The plan for such meetings should be noted in the application. Partnering PI Option: The Transformative Impact Award mechanism encourages multi-institutional applications. The Partnering PI Option under this award mechanism is structured to accommodate up to three PIs, each of whom will receive a separate award. One partner is identified as the Initiating PI and additional PIs are identified as Partnering PIs. The Initiating and Partnering PIs have different application submission requirements; however, each PI should contribute to the preparation of each of the application components. The PIs may have expertise in similar or disparate scientific disciplines. It is the responsibility of the collaborating investigators to describe how their efforts will combine and synergize to maximize the project’s outcomes. Oral Presentation: An oral presentation to the PCRP Integration Panel (IP) is a requirement for application review as described below: • Programmatic Review, Stage 2: A PI or Initiating PI whose application is selected for final consideration in Stage 2 of the Programmatic Review will be required to give an oral presentation that will be held in the National Capital Area in March 2014.

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