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NEWS RELEASE

Released: March 28, 2014

Defense Health Program
Department of Defense Prostate Cancer Research Program
Funding Opportunities for Fiscal Year 2014 (FY14)

The FY14 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 the 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. FY14 PCRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in April, May, and June 2014. 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.

The PCRP's FY14 mission is to find and fund research that will lead to the elimination of death from prostate cancer and enhance the well-being of men experiencing the impact of the disease. As such, the PCRP seeks to focus applications and direct funding by providing the following Overarching Challenges and Focus Areas to address critical needs in prostate cancer research and clinical management. Applicants are strongly encouraged to propose research that addresses the Overarching Challenges and Focus Areas.

Overarching Challenges: (1) Develop better tools for early detection of clinically relevant disease; (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; (4) Develop strategies to optimize physical and mental health of men with 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
IMPACT-BASED RESEARCH AWARDS
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. Biomarker discovery studies will not be supported.
  • Applications are encouraged but not required to address validation of multiple biomarkers and/or studies on use of imaging and serum biomarkers.
  • Multi-institutional efforts are required.
  • Presentation of robust preliminary data from test samples is required.
  • Availability and accessibility of samples and/or data must be demonstrated; use of pre-existing resources is highly encouraged.
  • 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 $2.25M 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
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
  • If not in an independent faculty position (or equivalent), have completed at least 3 years of postdoctoral training or fellowship
  • If in an independent faculty position (or equivalent), are within 5 years of having begun work as an independent investigator
  • Preproposal is required; application submission is by invitation only.
  • 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 or 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
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 (1) a validated target, (2) that either one lead agent or a limited number of agents for optimization has been established, 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.
  • Robust preliminary data are required, including target availability and distribution in relevant human tissues and information from model systems that supports potential efficacy of the agent or device in humans.
  • Supports research ranging 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
Population Science Impact Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Supports high-impact approaches to prostate cancer research from the perspective of population science studies, generating data and/or tools that can only be achieved from the perspective of systematic studies focused on specific populations of individuals. Studies should employ the logic, concepts, and methods of one or more population sciences: epidemiology, surveillance, health services research, outcomes research, behavioral science, social science, and dissemination research, among other areas.
  • Studies may utilize retrospective, prospective, case-control, cohort, or other designs provided that the study population is of sufficient size to provide appropriate statistical power.
  • Topics may include, but are not limited to, biomarkers, especially those relevant to aggressive disease; genetics/ genomics; therapy and predictors of response or resistance; survivorship and palliative care; and health disparity.
  • Requires a robust statistical plan and strong biostatistics expertise on the study team.
  • Certain types of clinical trials are allowed.
  • Maximum funding of $750K for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
INNOVATION-BASED RESEARCH AWARDS
Clinical Exploration Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Supports rapid execution of hypothesis-based, early phase clinical trials (e.g., Phase 0, Phase I, pilot Phase II) to test interventions that will have a major impact on prostate cancer management. Proposed studies should explore innovative and untested concepts to provide scientific rationale or initial proof-of-principle for larger clinical trials in prostate cancer.
  • Also supports patient-based, innovative, hypothesis-driven correlative studies associated with existing/ongoing clinical trials.
  • Interventions may include drugs, devices, biologics, surgical procedures, behavior modifications, or other types.
  • Investigational New Drug or Investigational Device Exemption approvals, if applicable, must be in place before an award will be made.
  • Clinical trials are expected to be initiated within 12 months of the award date.
  • Maximum funding of $450K for direct costs (plus indirect costs)
  • Maximum period of performance is 5 years
Exploration - Hypothesis Development Award Investigators at or above the level of 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 Institutional 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
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
  • If not in an independent faculty position (or equivalent), have completed at least 3 years of postdoctoral training or fellowship
  • If in an independent faculty position (or equivalent), are within 5 years of having begun work as an independent investigator
  • 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)
  • Maximum period of performance is 3 years
New Investigator Option:
  • Maximum funding of $225K 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
PROSTATE CANCER RESEARCH TRAINING AWARDS
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
Physician Research Training Award At the time of application submission, the PI (who is the trainee) must be either:
  • In the last year of an accredited medical residency or 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 March 31, 2015, 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
RESOURCE AWARDS
Prostate Cancer Biospecimen Resource Site Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Provides support for infrastructure that will facilitate participation in an existing PCRP-funded prostate cancer biorepository network through the collection, processing, annotation, storage, and distribution of high-quality human biospecimens.
  • Emphasis is on the procurement and provision of prostate cancer biospecimens currently in limited supply yet needed to address critical areas in prostate cancer research and biomarker development.
  • Applications will be submitted by biospecimen sites only; the biorepository Coordinating Center will be identified in the Program Announcement.
  • Applications must provide plans for biospecimen quality assurance, bioinformatics and data management, and ethical and regulatory issues.
  • Maximum funding of $400K for direct costs (plus indirect costs)
  • Maximum period of performance is 2 years

All applications must conform to the final Program Announcements and General 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 also 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 electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.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 Announcement release may be sent to help@eBRAP.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).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil