DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: March 4, 2020

Defense Health Program
Department of Defense Prostate Cancer Research Program
Anticipated Funding Opportunities for Fiscal Year 2020 (FY20)

The FY20 Defense Appropriations Act provides funding to the Department of Defense Prostate Cancer Research Program (PCRP) to support innovative, high-impact prostate cancer research. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

The PCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY20 funding opportunity. This pre-announcement should not be construed as an obligation by the Government. The FY20 PCRP Program Announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the Program Announcements are released. 

The mission of the FY20 PCRP is to fund research that will lead to the elimination of death from prostate cancer and enhance the well-being of Service members, Veterans, and all the men and their families who are experiencing the impact of the disease. Within this context, the PCRP is interested in supporting research that addresses specific gaps in prostate cancer research and clinical care, with an emphasis on investing in research that will benefit patients diagnosed with lethal prostate cancer or improve quality of life for men diagnosed with this disease. All applications are required to address one or more of the following FY20 PCRP Overarching Challenges: 

  • Improve the quality of life for survivors of prostate cancer
  • Develop treatments that improve outcomes for men with lethal prostate cancer

Applications must be directly relevant to lethal prostate cancer, which includes patients with metastatic disease; treatment-resistant disease; oligo-metastases; neuroendocrine disease; high-risk localized or locoregional disease, etc.

  • Reduce lethal prostate cancer in people of African descent, Veterans, and high-risk or underserved populations

High-risk populations include, but are not limited to, people of African descent (including Caribbean Americans), genetically predisposed populations, Service members, and Veterans. Underserved populations include, but are not limited to, men with limited access to clinical care and resources (in both rural and urban settings), and sexual and/or gender minorities with, or at risk for, prostate cancer.

  • Define the biology of lethal prostate cancer to reduce death

Applications must be directly relevant to lethal prostate cancer, which includes patients with metastatic disease; treatment-resistant disease; oligo-metastases; neuroendocrine disease; high-risk localized or locoregional disease; etc. Applications should not focus on topics such as differentiation between low risk and intermediate risk prostate cancer.

Award Mechanism Eligibility Key Mechanism Elements Funding
Early Investigator Research Award By March 31, 2021, Postdoctoral Principal Investigators (PIs):
  • Must possess a doctoral degree (or equivalent).
  • Have 3 years or less of postdoctoral research experience (excluding clinical residency or clinical fellowship training).
  • Supports research opportunities focused on prostate cancer for individuals in the early stages of their careers.
  • PIs must have a designated mentor who is an experienced prostate cancer researcher.
  • Maximum funding of $300,000 for direct costs (plus indirect costs).
  • Maximum period of performance is years.
Physician Research 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 5 years of having initiated a faculty appointment (including Instructor positions).
  • Supports a mentored research experience to prepare 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.
  • Maximum funding of $750,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 4 years.
Idea Development Award Established Investigators:
Independent investigators at all levels
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 and/or Health Disparity Research Award.
  • Have either completed at least 3 years of postdoctoral training or fellowship or are within 10 years after completion of terminal degree (excluding residency or family leave).
  • 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 one or more of the FY20 PCRP Overarching Challenges.
  • Emphasis is equally placed on Innovation and Impact.
  • Preliminary data are encouraged, but not required.
  • Clinical trials are not allowed.
  • Each PI may submit only one application.
  • New Investigator Option supports applicants early in their faculty appointments or in the process of developing independent research careers.
Established Investigators:
  • Maximum funding of $750,000 for direct costs (plus indirect costs).
New Investigators:
  • Maximum funding of $600,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.
Health Disparity Research Award Established Investigators:
Independent investigators at all levels
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 and/or Idea Development Award.
  • Have either completed at least 3 years of postdoctoral training or fellowship or are within 10 years after completion of terminal degree (excluding residency or family leave).
  • Supports research ideas that have the potential to make an important contribution to reducing and ultimately eliminating disparities in prostate cancer incidence, morbidity, and mortality.
  • Proposed projects must address one of the following health disparity focus areas: (1) access to healthcare, (2) social and cultural factors, (3) environmental factors, or (4) biological and genetic contributors.
  • Proposed projects may include basic, translational, population science, or clinical research, including clinical trials.
  • Primary emphasis will be placed on the potential impact of the proposed work.
  • 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.
Established Investigators:
  • Maximum funding of $750,000 for direct costs (plus indirect costs).
New Investigators:
  • Maximum funding of $600,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.
Translational Science Award

Modified for FY20
Independent investigators at all levels.
  • Supports advanced pre-clinical studies that will develop promising ideas with demonstrated clinical relevance in prostate cancer into clinical applications.
  • Supports a broad range of translational studies such as:
    • Translation of results from animal studies to applications with human samples/cohorts.
    • Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission.
    • Correlative studies that are associated with an open/ongoing or completed clinical trial.
    • Projects that develop endpoints for clinical trials.
  • Preliminary data required.
  • NEW Partnering PI Option: Allows two PIs, termed Initiating and Partnering PIs, to collaborate on a single application. Multidisciplinary collaborations are encouraged.
  • Maximum funding of $1,000,000 for direct costs (plus indirect costs).
  • Maximum period of performance is years.
Clinical Trial Award Independent investigators at all levels .
  • Supports 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 one or more of the FY20 PCRP Overarching Challenges.
  • 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 by the time of application submission.
  • Letter of support to demonstrate proof of possession of sufficient drug supply to conduct study must be provided (if appropriate).
  • Clinical trials are expected to be initiated within 12 months of the award date.
  • Maximum funding of $2,000,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 4 years.
Population Science and Outcomes Research Award

NEW for FY20
Independent investigators at all levels.
  • Supports population-focused studies that will, if successful, identify and understand predictors of lethal prostate cancer or survivorship within the context of the FY20 PCRP Overarching Challenges.
  • Examples of appropriate research approaches include:
    • Retrospective data analysis of patient databases or biospecimens.
    • Prospective observations, analyses, or sample collection from a patient population.
    • Case-control, cohort, or other population science study designs.
  • Clinical trials are not allowed.
  • Research ideas may include, but are not limited to, biomarkers for lethal disease; genetics/genomics; therapy and predictors of response or resistance; survivorship; and health disparity.
  • Requires demonstration of sufficient sample size to address the study objectives, a robust statistical plan, and strong biostatistical expertise in the study team.
  • Presentation of preliminary data is strongly encouraged, but not required.
  • Maximum funding of $1,000,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.
Clinical Consortium Award

Modified for FY20
Independent investigators with a faculty-level appointment (or equivalent).
  • 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 clinical trials that will bring to market high-impact, novel therapeutic interventions that will significantly decrease the impact of prostate cancer.
  • The coordinating center and clinical research sites will be jointly responsible for proposing, selecting, and conducting trials.
  • Funds may not be used for research or development of clinical protocols.
  • Significant emphasis is placed on the inclusion of patients from diverse populations, particularly those from high-risk (e.g., men of African descent, Caribbean Americans), underserved (e.g., men with limited access to clinical care and resources in rural or urban settings), and/or military populations (Service member and Veterans).
  • Coordinating Center applications will identify two or more Affiliate Clinical Research Sites to be supported and managed by the Coordinating Center that must specialize in the recruitment of patients from the emphasized populations.
  • Clinical Research Sites must provide plans for accruing patients from diverse patient populations.
Coordinating Center:
  • Maximum funding of $7,200,000 for direct costs (plus indirect costs), including no less than $500,000 per year for support of two or more Affiliate Clinical Research Sites.
  • Maximum period of performance is years.

Clinical Sites:

  • Maximum funding of $1,000,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 4 years.
Prostate Cancer Pathology Resource Network Award

Modified for FY20
Independent investigators with a faculty-level appointment (or equivalent) with access to the appropriate facilities.
  • Provides infrastructure support for the development and maintenance of a prostate cancer biorepository through a collaborative network across multiple institutions that will facilitate the collection, processing, annotation, storage, and distribution of high-quality human prostate cancer biospecimens.
  • Each application must include one Coordinating Center and three to five Pathology Resource Sites (including one at the Coordinating Center), all of which will be jointly responsible for development of the biospecimen repository.
  • Major emphasis for biospecimen collection must be placed on the acquisition and distribution of biospecimens in limited supply in the prostate cancer research community.
  • In addition to sample collection, the consortium is expected to be a repository for the collection and distribution of molecular data generated from the biospecimens, such as digital images and blood-based germline assessments.
  • Each application must include plans for significant accrual from at least one Pathology Resource Site of patient samples from populations that are disproportionately affected (African Americans, African-descent, Veterans, etc.) and underserved (uninsured, rural communities, etc.).
  • Sites must provide plans for scalable management operations, quality assurance, bioinformatics and data management, and ethical and regulatory issues.
  • Applications should clearly describe benchmarks for utilization of the repository as well as mechanisms for outreach to increase use by the prostate cancer community.
  • Maximum funding of $6.0M for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. 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 CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the PCRP or other CDMRP-administered programs, please visit the CDMRP website (https://CDMRP.HEALTH.MIL).

Point of Contact:

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


Last updated Tuesday, November 12, 2024