Opportunity Information: Apply for W81XWH 10 PCRP IA
Apply for W81XWH 10 PCRP IA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Prostate Cancer Research Program Impact Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on Apr 21, 2010 and posted on Feb 2, 2010.
- Applicants must submit their applications by Jun 9, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,400,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The DoD Prostate Cancer Research Program (PCRP) Impact Award (Funding Opportunity Number W81XWH-10-PCRP-IA) is a FY2010 funding mechanism from the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), designed to back a small number of highly ambitious projects that can make a major, practice-changing difference in one specific area of prostate cancer care: reducing or eliminating the overtreatment of primary prostate cancer. The central idea is that too many men diagnosed with early stage disease receive aggressive treatment even when their cancers may be indolent, and the program is looking for research that can meaningfully improve how clinicians decide who truly needs treatment and who can be safely monitored.
This opportunity uses a two-step application process. Applicants must first submit a pre-proposal (pre-application) by 5:00 p.m. Eastern Time on March 17, 2010, following instructions laid out in the Program Announcement. Full applications are not accepted from everyone; they are submitted by invitation only after the pre-proposals are screened. The award instrument is listed as a cooperative agreement or grant under the Science and Technology / Research and Development category, with an estimated total FY10 funding of about $2.4 million and an expectation of roughly two awards. Cost sharing is not required, and eligibility is broadly open (unrestricted) as long as the applicant meets any specific clarifications in the announcement.
In terms of the science, the Impact Award is explicitly geared toward hypothesis-driven research that aims to change the standard of practice for decision making in primary prostate cancer. Proposed work can be basic, translational, or clinical, and clinical trials are allowed, as long as the project remains tightly focused on the overtreatment problem. A common expectation for clinical studies is longitudinal follow-up that helps distinguish, as early as diagnosis, between patients whose disease will remain indolent and those whose disease is likely to progress to a lethal phenotype. The program signals that it values clinically meaningful endpoints tied to real decisions in care, such as progression and subsequent need for treatment, rather than purely exploratory or descriptive outcomes.
The scope of relevant approaches is intentionally broad, as long as the project clearly supports better risk stratification and more appropriate treatment selection. Examples of topic areas called out include active surveillance (such as improving or standardizing inclusion and exclusion criteria), biomarker development and validation, genetic analyses, improved staging and grading including imaging advances, better measures to guide decision making before and after biopsy, improved follow-up strategies and progression assessment, and cancer care outcomes research that captures patient-centered issues like quality of life, survivorship, and surveillance-related outcomes. The common thread across these areas is building evidence and tools that help clinicians avoid unnecessary intervention without missing aggressive disease that truly requires treatment.
Because this mechanism is labeled an "Impact Award" and is positioned as high-consequence, applications are expected to show feasibility up front. That means preliminary data are required, and the announcement emphasizes that these data should come from the principal investigator's lab or from members of the assembled research team, not from unrelated outside sources. Applicants are also expected to build a multidisciplinary team, typically involving multiple clinical specialists as needed for the question, and to include a robust statistical plan and statistical expertise. The intent is to ensure the study is designed to produce clear, credible answers that can support changes in clinical practice.
Human subjects research is permitted, including clinical trials. If the project involves clinical research, the program expects regulatory approvals to be obtained and the study to be initiated within the first year of the award, underscoring the urgency and translational intent of this mechanism. The responsibility is placed on the PI to explicitly connect the proposed research question to the program's goal of reducing overtreatment and to make a convincing case for impact, including a clear research strategy, appropriate access to any defined study population (for population-based work), and a realistic plan for generating results that could materially shift how early stage prostate cancer is managed.
Key dates listed in the announcement include the posted date of February 2, 2010, and a pre-proposal deadline of March 17, 2010 at 5:00 p.m. ET. The funding listing also shows an original closing date of April 19, 2010 and later updates extending the current closing date to June 9, 2010, with an archive date of July 9, 2010. For assistance, the announcement provides contacts for Program Announcement help (301-619-7079, cdmrp.pa@amedd.army.mil) and eReceipt/CDMRP help desk support (301-682-5507, help@cdmrp.org).
FAQs: DoD Prostate Cancer Research Program (PCRP) Impact Award (W81XWH-10-PCRP-IA)
What is the PCRP Impact Award?
The PCRP Impact Award is an FY2010 funding mechanism from the Department of the Army (USAMRAA) intended to support a small number of highly ambitious prostate cancer research projects that can create a major, practice-changing difference in care.
What is the single focus area for this Impact Award?
This opportunity is focused on one specific care problem: reducing or eliminating the overtreatment of primary (early stage) prostate cancer by improving how clinicians decide who needs treatment versus who can be safely monitored.
What does the program mean by "overtreatment" in primary prostate cancer?
The program highlights that many men diagnosed with early stage prostate cancer receive aggressive treatment even when their cancers may be indolent. The goal is research that meaningfully improves decision making so unnecessary intervention is avoided without missing aggressive disease that truly requires treatment.
Who is the sponsoring organization for this award?
The award is offered through the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under the DoD Prostate Cancer Research Program (PCRP).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is W81XWH-10-PCRP-IA.
What type of award instrument is expected?
The listing describes the award instrument as a cooperative agreement or grant.
What category does this opportunity fall under?
The opportunity is listed under Science and Technology / Research and Development.
How much total funding is estimated for FY2010?
The estimated total FY2010 funding is about $2.4 million.
How many awards does the program expect to make?
The program expects to make roughly two awards.
Is cost sharing required?
No. Cost sharing is not required.
Who is eligible to apply?
Eligibility is described as broadly open (unrestricted), as long as the applicant meets any specific clarifications in the announcement.
Is the application process one step or two steps?
It is a two-step application process: first a pre-proposal (pre-application), followed by an invited full application for those selected after screening.
What is the pre-proposal deadline?
Pre-proposals are due by 5:00 p.m. Eastern Time on March 17, 2010.
Can anyone submit a full application?
No. Full applications are submitted by invitation only after pre-proposals are screened.
Where do applicants find the instructions for the pre-proposal?
The pre-proposal must be submitted following the instructions in the Program Announcement.
What kinds of research are allowed (basic, translational, clinical)?
Basic, translational, and clinical research are all allowed, as long as the project remains tightly focused on reducing overtreatment of primary prostate cancer and aims to change decision making in standard practice.
Are clinical trials allowed under this mechanism?
Yes. Clinical trials are allowed, provided they remain tightly focused on the overtreatment problem.
What is the program looking for in terms of impact?
The program is explicitly geared toward hypothesis-driven research that can change the standard of practice for decision making in primary prostate cancer, with clinically meaningful endpoints tied to real decisions in care.
What types of endpoints does the program value?
The program signals preference for clinically meaningful endpoints tied to care decisions, such as progression and subsequent need for treatment, rather than purely exploratory or descriptive outcomes.
Is longitudinal follow-up expected for clinical studies?
Yes. A common expectation for clinical studies is longitudinal follow-up that helps distinguish, as early as diagnosis, between indolent disease and disease likely to progress to a lethal phenotype.
What topic areas are specifically mentioned as relevant examples?
Examples include active surveillance (improving or standardizing inclusion/exclusion criteria), biomarker development and validation, genetic analyses, improved staging and grading (including imaging advances), measures to guide decision making before and after biopsy, improved follow-up strategies and progression assessment, and cancer care outcomes research including patient-centered issues such as quality of life, survivorship, and surveillance-related outcomes.
Does the program require preliminary data?
Yes. Because this is an Impact Award aimed at high-consequence outcomes, applications are expected to show feasibility up front, and preliminary data are required.
Whose preliminary data are considered acceptable for feasibility?
The announcement emphasizes that preliminary data should come from the principal investigator's lab or from members of the assembled research team, not from unrelated outside sources.
Is a multidisciplinary team expected?
Yes. Applicants are expected to build a multidisciplinary team, typically involving multiple clinical specialists as needed for the research question.
Is statistical expertise required?
The program expects a robust statistical plan and statistical expertise to ensure the study design produces clear, credible answers that can support changes in clinical practice.
Is human subjects research permitted?
Yes. Human subjects research is permitted, including clinical trials.
If the project includes clinical research, what does the program expect in the first year?
If the project involves clinical research, the program expects regulatory approvals to be obtained and the study to be initiated within the first year of the award.
How should applicants connect their proposal to the program goal?
The responsibility is on the PI to explicitly connect the proposed research question to reducing overtreatment and to make a convincing case for impact with a clear research strategy.
What does the announcement say about access to study populations?
For population-based work, the application is expected to demonstrate appropriate access to any defined study population.
What are the key dates listed in the announcement?
Key dates include a posted date of February 2, 2010; a pre-proposal deadline of March 17, 2010 at 5:00 p.m. ET; an original closing date of April 19, 2010; updates extending the current closing date to June 9, 2010; and an archive date of July 9, 2010.
Who should be contacted for Program Announcement help?
For Program Announcement help, contact 301-619-7079 or email cdmrp.pa@amedd.army.mil.
Who should be contacted for eReceipt/CDMRP help desk support?
For eReceipt/CDMRP help desk support, contact 301-682-5507 or email help@cdmrp.org.
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