OpportunityTitle: DoD FY11 Prostate Cancer Research Program Impact Award
Description: The PCRP Impact Award mechanism was first offered in FY10. Since then, 22 Impact Award applications have been received, and 3 have been recommended for funding. The PCRP Impact Award supports research projects specifically focused on making a major impact on one critical issue in prostate cancer: reducing or eliminating the over-treatment of primary prostate cancer. Projects funded by this award will, if successful, ultimately change the standard of practice for decision-making in the treatment of primary prostate cancer. As such, it is expected that all projects for the Impact Award will address the PCRP overarching challenge to &#239;&#191;&#189;distinguish aggressive from indolent disease.&#239;&#191;&#189; Studies conducted under the Impact Award may include the wide spectrum of basic to clinical research, including clinical trials, provided the overall project is hypothesis-based, focused on the problem of prostate cancer over-treatment, and includes a sound overall research strategy. It is anticipated that studies supported by this award will facilitate assessment of the decisionmaking process for early stage prostate cancer using clinically relevant endpoints such as clinical progression, need for treatment, and/or other endpoints. Research proposed under the Impact Award may include, but is not limited to, the following areas that will address the over-treatment of primary prostate cancer: &#239;&#191;&#189; Development of surveillance mechanisms, including improvements in current clinical and diagnostic tools to monitor prostate cancer patients (e.g., to standardize inclusion/exclusion criteria) &#239;&#191;&#189; Biomarkers to inform decision-making &#239;&#191;&#189; Genetic analyses to inform decision-making &#239;&#191;&#189; Improved staging, to include imaging &#239;&#191;&#189; Optimal measures to inform decision-making pre- and post biopsy &#239;&#191;&#189; Optimal measures for follow-up and assessment of progression &#239;&#191;&#189; Cancer care outcomes research (e.g., quality of life, survivorship) and surveillance In addition, Principal Investigators (PIs) are expected to address the following considerations, if applicable: &#239;&#191;&#189; For studies using model systems (e.g., cell animal), include strong justification for why the hypothesis cannot be tested in humans and how the results can be expeditiously validated in a predetermined source of human samples. &#239;&#191;&#189; For studies designed from population-based perspectives, include a clearly defined population and evidence of appropriate access to the population (and/or access to available samples/data or database(s) to immediately initiate the project). &#239;&#191;&#189; For clinical studies, include longitudinal follow-up to differentiate, at the time of diagnosis, between patients whose disease is indolent and those whose disease will progress to the aggressive phenotype. PIs applying for the PCRP Impact Award are expected to establish a multi-disciplinary study team that possesses an appropriate level of prostate cancer-related expertise and may include a variety of clinical specialists to effectively address the proposed question. PIs whose study designs require human specimens are encouraged to collaborate with personnel affiliated with established prostate cancer biorepositories. A robust statistical plan and statistical expertise should be included in the proposed investigation as well as demonstrated access to, and availability of all samples and data necessary for the study so that the project can commence immediately after an award is made. Study teams for clinical trials must include a Study Coordinator who will guide the clinical protocol through IRB review and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate human subject accrual. 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 member(s) of the research team. Research involving human subjects, including clinical trials, is permitted under this Program Announcement/Funding Opportunity. If the proposed study involves clinical research (including clinical trials), it is expected that regulatory approval will be obtained and the research initiated within the first year of the award. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For more information on clinical trials, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms/. It is the intent of the PCRP Impact Award that data and research resources generated by funded research activities be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large. Each proposal should include a data- and/or research resource-sharing plan describing how unique and/or final research data will be shared, along with any resulting research resources. This information should be provided as the Data- and Research Resource-Sharing Plan as described in Section II.C., Application Submission Content and Form, of this Program Announcement/Funding Opportunity. Refer also to the General Application Instructions, Appendix 4, for more information.
GrantorContactEmailDescription: CDRMP Help Desk
GrantorContactText: 301-682-5507