DoD FY11 Prostate Cancer Research Program Impact Award | Apply Online

FAQs: DoD FY11 Prostate Cancer Research Program (PCRP) Impact Award (W81XWH-11-PCRP-IA)

1. What is the funding opportunity number for this award?

The funding opportunity number is W81XWH-11-PCRP-IA.

2. What program is offering this award?

This opportunity is offered under the DoD FY11 Prostate Cancer Research Program (PCRP) Impact Award and is a Department of the Army/USAMRAA funding opportunity.

3. What is the main purpose of this Impact Award?

The award targets one specific, high-consequence problem in prostate cancer care: reducing or eliminating the overtreatment of primary (early stage) prostate cancer.

4. What does the program mean by reducing overtreatment in early stage prostate cancer?

The intent is to improve the ability to distinguish aggressive disease from indolent disease so that men who do not need immediate treatment can be safely identified and spared unnecessary interventions and side effects.

5. What kind of impact is the program expecting from funded projects?

Successful projects are expected to lead to a meaningful shift in real-world clinical decision making and potentially change the standard of practice for managing primary (early stage) prostate cancer.

6. What overall challenge must the research address to fit this mechanism?

The work is expected to directly address the PCRP overarching challenge of distinguishing aggressive prostate cancer from indolent disease to guide surveillance versus intervention decisions.

7. What research areas are allowed within the scope of this award?

The scope is deliberately broad and can include basic, translational, and clinical research, including clinical trials, as long as the project is hypothesis-driven, tightly focused on the overtreatment problem, and supported by a sound, coherent research strategy.

8. Are clinical trials allowed under this solicitation?

Yes. Clinical research and clinical trials are allowed.

9. How does this opportunity define a clinical trial?

A clinical trial is defined as prospective accrual of human subjects testing an intervention (for example, a drug, device, biologic, procedure, behavioral intervention, or similar) for measurable outcomes related to safety, effectiveness, efficacy, or exploratory endpoints.

10. What endpoints does the program emphasize?

The program emphasizes clinically relevant endpoints that reflect real-world early stage decision making, such as clinical progression, the need for treatment, and other practical outcome measures that can guide surveillance versus intervention pathways.

11. What example research topics does the solicitation highlight as fitting the goal?

Examples include improved surveillance mechanisms and monitoring tools (including efforts to standardize inclusion and exclusion criteria for surveillance), biomarkers and genetic analyses that sharpen treatment decisions, better staging approaches including imaging, stronger decision tools used before and after biopsy, optimized follow-up strategies to assess progression, and outcomes research tied to surveillance (including quality of life, survivorship, and patient-centered outcomes).

12. Does the program require the project to be hypothesis-driven?

Yes. Proposed work is expected to be hypothesis-driven and supported by a sound, coherent research strategy.

13. What does the program mean by “operationally ready” applications?

Reviewers are expected to look for demonstrated access to needed samples, data, and/or patient populations so the project can start promptly after award.

14. Is a team-based approach expected?

Yes. Applications are expected to be team-based, with a multidisciplinary team that has appropriate prostate cancer expertise and includes strong statistical leadership and a robust statistical plan.

15. What are the expectations for statistical leadership and planning?

The announcement emphasizes including strong statistical leadership along with a robust statistical plan as part of the multidisciplinary team approach.

16. What must applicants show regarding access to samples, data, or patient populations?

Applicants are expected to demonstrate access to the samples, data, and/or patient populations needed to begin promptly after award.

17. Are collaborations with biorepositories encouraged?

Yes. If a project requires human specimens, collaboration with established prostate cancer biorepositories is encouraged.

18. What is required for proposals using population-based approaches?

Proposals relying on population-based approaches need to clearly define the target population and provide evidence that the team can access the population, datasets, and/or biospecimens without delay.

19. What additional expectations apply to projects using model systems (cell or animal)?

Applicants should justify why the hypothesis cannot be tested directly in humans and provide a concrete plan to validate findings quickly using a predefined set of human samples.

20. What additional expectations apply to clinical studies?

Clinical study designs are expected to include longitudinal follow-up capable of differentiating, as early as the time of diagnosis, patients whose disease is likely to remain indolent from those likely to progress to an aggressive phenotype.

21. If a clinical trial is proposed, what timeline expectation is stated?

For clinical trials, the program expects regulatory approvals to be obtained and the study to be initiated within the first year of the award.

22. Is a Study Coordinator required for clinical trial proposals?

Yes. For trial proposals, the team must include a Study Coordinator to manage IRB and other regulatory processes, coordinate multi-site activities, and support participant accrual.

23. Is feasibility a formal requirement?

Yes. Feasibility is described as a firm requirement.

24. Are preliminary data required as part of the application?

Yes. Applications must include preliminary data.

25. Can unpublished preliminary results be used, and are there restrictions?

Unpublished preliminary results may be included, but they should come from the PI or members of the proposing team rather than from unrelated external sources.

26. Are awardees expected to share data and research resources?

Yes. Funded teams are expected to share resulting data and research resources broadly with the research community (including consumer advocacy communities) and the public.

27. What must be included regarding data and/or resource sharing?

Each application must include a data and/or research resource sharing plan that explains what will be shared, how it will be shared, and what resources (datasets, materials, tools) will be made available.

28. What is the funding instrument for this opportunity?

The funding instrument is listed as a cooperative agreement grant.

29. Is cost sharing or matching required?

No. The opportunity states there is no cost sharing or matching requirement.

30. How many awards were anticipated?

The program anticipated making about 2 awards.

31. What was the estimated total funding amount?

The estimated total funding amount was $2.4 million.

32. Who is eligible to apply?

Eligibility is listed as unrestricted (open to any type of entity), subject to any clarifications in the full announcement.

33. What is the CFDA number for this program?

The CFDA number is 12.420 (Military Medical Research and Development).

34. When was this opportunity posted, and what were the key dates?

The opportunity was posted May 5, 2011. The original and current closing date was September 1, 2011, and the archive date was October 1, 2011.

35. What category is this opportunity listed under?

It is listed within the science and technology/research and development category.

36. Where can applicants get help with technical access issues?

For technical access issues, the announcement provides the CDMRP Help Desk number: 301-682-5507.

37. Are there referenced guidance materials for human subjects and clinical trials?

Yes. The opportunity references CDMRP human subjects and clinical trials guidance materials available through the CDMRP program announcements and forms page.