The synopsis for this grant opportunity is detailed below, following
this paragraph. This synopsis contains all of the updates to this
document that have been posted as of
updates have been made to the opportunity synopsis, update information
is provided below the synopsis.
If you would like to receive notifications of changes to the grant
me change notification emails
The only thing you need to provide for this service is your email
address. No other information is requested.
Any inconsistency between the original printed document and the disk
or electronic document shall be resolved by giving precedence to the
Funding Opportunity Number:
May 05, 2011
May 05, 2011
Original Closing Date for Applications:
Sep 01, 2011
Current Closing Date for Applications:
Sep 01, 2011
Oct 01, 2011
Funding Instrument Type:
Category of Funding Activity:
Science and Technology and other Research and Development
Expected Number of Awards:
Estimated Total Program Funding:
Military Medical Research and Development
Cost Sharing or Matching Requirement:
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Additional Information on Eligibility:
Dept. of the Army -- USAMRAA
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 �distinguish aggressive from indolent disease.� 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:
� Development of surveillance mechanisms, including improvements in current clinical
and diagnostic tools to monitor prostate cancer patients (e.g., to standardize
� Biomarkers to inform decision-making
� Genetic analyses to inform decision-making
� Improved staging, to include imaging
� Optimal measures to inform decision-making pre- and post biopsy
� Optimal measures for follow-up and assessment of progression
� 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:
� 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.
� 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).
� 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.
Link to Additional Information
If you have difficulty accessing the full announcement
electronically, please contact: