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NEWS RELEASE

Released: April 12, 2013

Defense Health Program
Department of Defense Prostate Cancer Research Program
Funding Opportunities for Fiscal Year 2013 (FY13)

The FY13 Defense Appropriations Act provides $80 million (M) to the Department of Defense Prostate Cancer Research Program (PCRP) to support innovative, high-impact prostate cancer research. This program is administered by the US Army Medical Research and Materiel Command (USAMRMC) through the Office of Congressionally Directed Medical Research Programs (CDMRP).

The PCRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY13 PCRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in May and June 2013. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the government.

IMPORTANT: The PCRP's FY13 mission is to find and fund research that will lead to the elimination of death and enhance the well-being of men with prostate cancer. As such, the PCRP seeks to focus applications and direct funding by providing three Overarching Challenges and seven Focus Areas to address critical needs in prostate cancer research and clinical management. Applicants are strongly encouraged to submit research that addresses one or more of the Overarching challenges and Focus Areas.

Overarching Challenges: (1) Develop better tools to detect clinically relevant disease in asymptomatic men; (2) Distinguish aggressive from indolent disease in men newly diagnosed with prostate cancer; (3) Develop effective treatments and address mechanisms of resistance for men with high-risk or metastatic prostate cancer

Focus Areas: (1) Biomarker Development; (2) Genetics; (3) Imaging; (4) Mechanisms of Resistance; (5) Survivorship and Palliative Care; (6) Therapy; and (7) Tumor and Microenvironment Biology

Award Mechanism Eligibility Key Mechanism Elements Funding
Biomarker Development Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal required; application submission by invitation only.
  • Supports high-impact research aimed at analytical validation or qualification of known prostate cancer biomarkers or biomarker assays for rapid transfer to clinical practice. Biomarkers may be prognostic, predictive, or pharmocodynamic. This award mechanism does not support biomarker discovery studies.
  • Highly encouraged are applications that address validation of multiple biomarkers and/or studies on use of imaging and serum biomarkers.
  • Applications should address tumor heterogeneity and possible sampling artifacts.
  • Multi-institutional efforts are highly encouraged.
  • Presentation of robust preliminary data from test samples is required.
  • Principal Investigators (PIs) must demonstrate availability and accessibility of samples and/or data and are encouraged to utilize pre-existing biospecimen resources.
  • Partnering PI option allows for individual awards to multiple sites (maximum of three sites in total), provided the combined direct costs for all sites does not exceed the $3M maximum.
  • Studies are expected to be initiated within 6 months of the award date.
  • Maximum funding of $2.25M for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Clinical Consortium Award Independent investigators at or above the level of Assistant Professor (or equivalent) with experience in performing multi-institutional prostate cancer clinical trials
  • Supports a consortium consisting of 1 coordinating center and 10 clinical research sites that will facilitate the rapid execution of collaborative Phase II or Phase I/II prostate cancer clinical trials.
  • The coordinating center and clinical research sites will be jointly responsible for proposing, selecting, and conducting clinical trials.
  • Sites must provide plans for accruing patients from populations disproportionately affected by prostate cancer as well as patients for biomarker validation studies.
  • Trials that incorporate clinical validation of novel biomarkers for risk assessment, early detection, prediction of aggressiveness, and/or progression are strongly encouraged.
  • The coordinating center is required to bring two or more affiliate sites to the consortium (in addition to the 10 that will be supported through separate awards).
  • The consortium is expected to achieve and foster financial self-sufficiency such that operations can continue after the awards end.
Coordinating Center:
  • Maximum funding of $3.6M for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Clinical Sites:
  • Maximum funding of $600 thousand ($600K) for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Collaborative Undergraduate Historically Black Colleges and Universities (HBCU) Student Summer Training Program Award Independent investigators at or above the level of Assistant Professor (or equivalent) with a proven record in prostate cancer research and training
  • Supports new or existing summer training programs for undergraduate HBCU students at host institutions with thriving prostate cancer research programs.
  • Must enroll a minimum of four undergraduate HBCU trainees per year.
  • Host institution must have a record of achievement in prostate cancer research and training.
  • Maximum funding of $185K for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Exploration - Hypothesis Development Award Investigators at or above postdoctoral fellow (or equivalent)
  • Supports the exploration of highly innovative, untested, potentially groundbreaking concepts in prostate cancer.
  • Emphasis is on innovation; potential impact may be difficult to predict.
  • Human subject studies are permitted provided the studies are exempt from or eligible for expedited internal review board review.
  • The presentation of preliminary data is strongly discouraged.
  • Maximum funding of $75K for direct costs (plus indirect costs)
  • Maximum period of performance is 1 year
Health Disparity Research Award Established Investigators: Independent investigators at or above the level of Assistant Professor (or equivalent); or
New Investigators: Investigators that meet the following criteria at the application submission deadline date:
  • Have the freedom to pursue individual aims without formal mentorship
  • Have not previously received a PCRP Health Disparity Research Award
  • Have either completed at least 3 years of postdoctoral training or fellowship or are within 5 years of having begun first independent faculty position (or equivalent)
  • Supports new ideas for prostate cancer research that have the potential to make an important contribution to reducing and ultimately eliminating disparities in prostate cancer incidence, morbidity, and mortality.
  • Preliminary data are encouraged but not required.
  • New Investigator Option supports applicants early in their faculty appointments or in the process of developing independent research careers.
  • Qualified Collaborator Option supports a higher level of funding for PIs who include a collaborator that significantly contributes (10% level of effort or greater and provides both intellectual input and research resources) to the research project such that it could not otherwise be accomplished.
  • Nested Health Disparity (HD) Traineeship Option supports predoctoral and postdoctoral training, nested within the overall proposed project, for individuals committed to pursuing careers as independent investigators in prostate cancer health disparity research.
  • Maximum funding of $450K for direct costs (plus indirect costs)
  • If applying for the Qualified Collaborator Option, maximum funding of $600K for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
  • Additional funds can be requested if including the Nested HD Traineeship Option
Idea Development Award Established Investigators: Independent investigators at or above the level of Assistant Professor (or equivalent); or
New Investigators: Investigators that meet the following criteria at the application submission deadline date:
  • Have the freedom to pursue individual aims without formal mentorship
  • Have not previously received a PCRP Idea Development Award
  • Have either completed at least 3 years of postdoctoral training or fellowship or are within 5 years of having begun first independent faculty position (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Supports new ideas that represent innovative, high-risk/high-gain approaches to prostate cancer research, and have the potential to make an important contribution to eliminating death and enhancing the well-being of men with prostate cancer.
  • Preliminary data are encouraged but not required.
  • Innovation and Impact are the most important review criteria.
  • Clinical trials are not allowed.
  • New Investigator Option supports applicants early in their faculty appointments or in the process of developing independent research careers.
Established PIs:
  • Maximum funding of $375K for direct costs (plus indirect costs)
New Investigator Option:
  • Maximum funding of $225K for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Laboratory - Clinical Transition Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Supports product-driven preclinical studies of promising novel lead agents or medical devices that have the potential to revolutionize prostate cancer clinical care.
  • For lead agents, PIs are expected to demonstrate within the application (1) a validated target, (2) access to either one lead agent or a limited number of agents for optimization, and (3) the agent's mechanism of action.
  • For devices, PIs are expected to demonstrate reliability, reproducibility, and effectiveness (including sensitivity and specificity) for the medical device.
  • The presentation of robust preliminary data is required, including target availability and distribution in relevant human tissues and substantive information from model systems that supports potential efficacy of the agent or device in humans.
  • Supports research that ranges from preclinical study through current Good Manufacturing Practices production.
  • Collaboration with commercial partners is highly encouraged.
  • Maximum funding of $1.5M for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Physician Research Training Award At the time of application submission, the PI must be either:
  • In the last year of an accredited medical residency or medical fellowship program;

    or
  • Within 3 years of having initiated an appointment as Instructor, Assistant Professor, or equivalent
  • Supports training of physicians with clinical duties for careers in prostate cancer research.
  • PIs must demonstrate a commitment to a career at the forefront of prostate cancer research and clinical practice.
  • PIs must have a designated mentor with an established research program in prostate cancer.
  • Institutions must provide at least 40% protection of PI's time for research.
  • Projects that focus on providing training in basic research are highly encouraged.
  • Maximum funding of $130K per year for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Postdoctoral Training Award By December 31, 2013, the PI must:
  • Have successfully defended a doctoral thesis or possess an M.D. degree, and
  • Have 3 years or less of postdoctoral fellowship experience
  • Supports prostate cancer research training opportunities for postdoctoral trainees who are recent doctoral graduates.
  • PIs must have a designated mentor who is an experienced prostate cancer researcher.
  • Maximum of $115K for direct costs (plus indirect costs up to a maximum rate of 8%)
  • Maximum period of performance is 2 years
Population-Based Impact Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Supports high-impact approaches to prostate cancer research from the perspective of population-based studies. These studies should address at least one of the PCRP overarching challenges using the logic, concepts, and methods of one or more population sciences, to include but not limited to: epidemiology, surveillance, health services research, outcomes research, behavioral science, social science, and dissemination research, among other areas.
  • Research outcomes must have the potential for near-term impact for men at risk for cancer and/or men with prostate cancer, for example, within epidemiologic cohorts, defined communities, or health systems.
  • Population-based studies may include retrospective, prospective, case-control, cohort, or other population-based study designs provided that the study population is of sufficient size to provide appropriate statistical power.
  • Topics may include, but are not limited to, epidemiology, molecular genetics, genomics, prevention, risk factors, risk prediction, disease aggressiveness, lethal phenotype, predictors of therapeutic response and progression, and health disparity.
  • Requires a robust statistical plan and strong biostatistical expertise on the study team.
  • Clinical trials are not allowed.
  • Maximum funding of $750K for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Prostate Cancer Pathology Resource Network Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Provides support for a consortium infrastructure that will facilitate prostate cancer research through the collection, processing, annotation, storage, and distribution of high-quality human biospecimens in a collaborative fashion across multiple institutions.
  • Emphasis will be placed on the procurement of metastatic and other rare prostate cancer biospecimens that will help to address critical areas in prostate cancer research and biomarker development.
  • Applications will be submitted by a Coordinating Center and should include two to four Pathology Resource Sites, all of which will be jointly responsible for development of the biospecimen repository.
  • Applications must provide plans for biospecimen quality assurance, bioinformatics and data management, ethical and regulatory issues, and plans for acquiring samples from populations disproportionately affected by prostate cancer.
  • Applications are encouraged from investigators with enhanced skills in human biospecimen procurement, human tissue repositories, distribution, and working within a collaborative network of multiple institutions.
  • Partnering PI option allows for individual awards to multiple sites (maximum of three sites in total), provided the combined direct costs for all sites does not exceed the $3M maximum.
  • Network investigators are expected to provide plans for securing funds from other agencies to leverage Network resources and for ongoing operations.
Coordinating Center:
  • Maximum funding of $3M for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Synergistic Idea Development Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Supports new or existing partnerships between two or three independent investigators to address a central innovative question or problem in prostate cancer that may include high risk, provided there is a potential for significant impact.
  • PIs are expected to demonstrate within the application the synergistic components (i.e., leveraging disciplines, expertise or critical resources) that will significantly advance the project such that the research outcomes as a whole will be realized rapidly and efficiently and could not otherwise be accomplished through independent efforts of a single PI.
  • Preliminary data are encouraged but not required.
  • Synergy, Innovation, and Impact are the most important review criteria.
  • Clinical trials are not allowed.
  • Maximum funding of $750K for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Transformative Impact Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Supports prostate cancer research efforts with near-term, transformative impact for prostate cancer patients.
  • Research efforts based on team science are expected, with support by a lead PI with demonstrated success in leading large, focused projects.
  • Consistent with the goal of near-term benefit for patients, the scope of the research effort must include translational studies, clinical research, and/or clinical trials.
  • Applicants must demonstrate that they are prepared to initiate the study immediately upon receiving the award (i.e., as of the award date).
  • Partnering PI option allows for individual awards to multiple sites (maximum of three sites in total), provided the combined direct costs for all sites does not exceed the $5M maximum.
  • Maximum funding of $5M for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years

All applications must conform to the final program announcements and application instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will be found on Grants.gov. A listing of all USAMRMC funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

A pre-application is required and must be submitted through the CDMRP eReceipt website (http://cdmrp.org) prior to the pre-application deadline. Applications must be submitted through the federal government's single-entry portal, Grants.gov. Submission deadlines are not available until the Program Announcements are released. Requests for email notification of the Program Announcements release may be sent to help@cdmrp.org. Email notifications of funding opportunities are sent as a courtesy and should not be used as a sole source of notification; applicants should monitor Grants.gov for official postings of funding opportunities.

For more information about the PCRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

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