DoD Prostate Cancer Exceptional Responders Award | Apply Online

FAQs: DoD Prostate Cancer Exceptional Responders Award (ERA) (FY15)

What is the DoD Prostate Cancer Exceptional Responders Award (ERA)?

The Exceptional Responders Award (ERA) is a Fiscal Year 2015 funding opportunity under the Department of Defense (DoD) Prostate Cancer Research Program (PCRP). It was introduced for the first time in FY15 and is designed to support a major research effort led by experienced prostate cancer investigators.

What is the main goal of the ERA?

The central goal is to determine why a small subset of prostate cancer patients show unusually strong, durable, or otherwise outlier responses to treatment, and to convert those rare outcomes into actionable knowledge that can improve clinical management (e.g., predicting outcomes, selecting therapies, reducing harm, and planning long-term follow-up).

Who or what counts as an "exceptional responder" in this program?

An exceptional responder is a patient whose disease outcome differs sharply from what is typically expected for a given prostate cancer therapy. Applicants are expected to clearly and defensibly define how exceptional responders will be identified in their proposed study.

Do applicants need to define inclusion and exclusion criteria for exceptional responders?

Yes. Applicants are expected to specify inclusion and exclusion criteria, identify which therapy or therapies are being examined, and explain how exceptional response will be measured.

How can an exceptional response be measured under this opportunity?

The opportunity indicates that exceptional response may be measured using clinically meaningful endpoints such as depth of response, durability, progression-free interval, overall survival, biomarker response, or other appropriate endpoints.

What types of research approaches are allowed (discovery-driven vs. target-driven)?

Both discovery-driven studies (broadly looking for patterns and signals) and target-driven studies (testing more defined hypotheses) are allowed, as long as the work includes an in-depth examination of unusual responses and translates findings into broadly relevant insights.

Is the ERA intended to fund a narrow, single-gene or single-pathway molecular biology project?

No. The solicitation emphasizes that the intent is not simply to add another molecular biology study focused on one pathway or one gene. The emphasis is on identifying what is truly distinctive about exceptional responders as people and as clinical cases, and producing insights with broad relevance.

What factors can be examined to understand exceptional responses?

The "what is unique" lens may include tumor biology, host biology, immune factors, treatment history, clinical features, behavioral elements, and lifestyle-related variables, as long as the study is built around understanding predictors of exceptional outcomes and how those predictors could change clinical decision-making.

What broader prostate cancer issues does the ERA encourage applicants to address?

The solicitation stresses projects that tackle overarching issues with broad implications for prostate cancer and risk management, including individual-level and systems-level risk factors, treatment-related considerations, toxicity and tolerability, and dormancy (such as why disease may remain controlled or quiescent far longer than expected in some patients).

Are projects expected to produce generalizable findings beyond single cases?

Yes. The program signals interest in work that does more than explain a single case and instead identifies generalizable predictors and mechanisms that could guide patient stratification, monitoring strategies, and personalized therapy choices across the broader prostate cancer population.

Do applicants need to specify which therapies are being studied?

Yes. Applicants are expected to specify the therapy or therapies being examined when defining how exceptional responders will be identified and studied.

Are any specific therapy areas encouraged?

The program encourages consideration of any prostate cancer therapy where treated patients show widely disparate responses, and it particularly encourages projects focused on exceptional responses to androgen deprivation therapies.

What comparison groups are expected in an ERA study?

The opportunity indicates that strong applications would typically be expected to explain how cases and comparison groups will be assembled and validated, alongside the definition and measurement of exceptional response.

What PCRP requirements must every ERA proposal meet?

Every ERA proposal is required to address at least one of the PCRP overarching challenges and must address the PCRP focus area called Mechanisms of Resistance.

Why does the ERA require addressing "Mechanisms of Resistance" if it focuses on exceptional responders?

The requirement reflects the idea that understanding why resistance does not emerge, or emerges differently, in exceptional responders can reveal leverage points for overcoming resistance in more typical patients.

Are applications expected to address more than one PCRP focus area?

Yes. The announcement notes that applications are expected to address more than one PCRP focus area, reinforcing the interest in integrated, clinically relevant work rather than narrow, single-factor studies.

Which agency and administrative office offered this opportunity?

This opportunity was offered as a discretionary funding program through the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), within the Military Medical Research and Development CFDA listing.

What is the CFDA number associated with this opportunity?

The opportunity is listed under CFDA 12.420 (Military Medical Research and Development).

What type of funding instrument is used for the ERA?

The funding instrument type is a cooperative agreement grant, which indicates the funding agency may anticipate substantial involvement during the period of performance compared with a standard grant mechanism.

How much funding was estimated to be available, and how many awards were expected?

The estimated total funding amount was $4,000,000, with an expectation of making one award.

Was cost sharing or matching required?

No. Cost sharing or matching was not required.

Who was eligible to apply?

Eligibility was listed as unrestricted (open to any entity type), subject to any additional eligibility details contained in the full announcement.

When was the opportunity posted, and what were the closing dates?

The opportunity was posted on May 20, 2015. The original and final closing date was September 24, 2015. The archive date was October 24, 2015.

Who should be contacted for access issues related to the full announcement?

For access issues related to the full announcement, the point of contact listed was the CDMRP Help Desk at 301-682-5507.