Opportunity Information: Apply for W81XWH 20 PCRP CTA
The FY20 DoD Prostate Cancer Research Program (PCRP) Clinical Trial Award is designed to speed up the development of new ways to reduce the burden of prostate cancer by funding early-stage clinical testing in people. The focus is on rapid launch and execution of early-phase trials such as Phase 0, Phase I, and pilot Phase II studies. Projects can test brand-new interventions or repurpose existing ones for new prostate cancer uses, but they must be hypothesis-driven treatment approaches and should be positioned to make a major impact on one or more of the program's FY20 PCRP Overarching Challenges. The program is aiming for results that can justify and propel larger, later-stage efficacy trials and ultimately change real-world prostate cancer care by improving outcomes like survival and quality of life.
A key point is that this award must fund an actual clinical trial and cannot be used for preclinical work. In this announcement, a clinical trial is defined in the standard federal way: a research study where one or more human subjects are prospectively assigned to one or more interventions (including placebo or control, if relevant) to measure effects on biomedical or behavioral health-related outcomes. The types of trials they consider appropriate include studies that help identify the right patient population for future trials, establish dose and delivery strategies, test feasibility in prostate cancer settings, and evaluate early signals of efficacy and safety. Interventions are broadly defined and can include drugs, devices, biologics, targeted radionuclides, surgical approaches, behavior-change interventions, or other strategies investigators can justify.
Because these are human studies that often involve regulated products, the funding opportunity places heavy emphasis on regulatory readiness. If the intervention is a drug or biologic that requires an Investigational New Drug (IND) application under 21 CFR 312, the applicant is responsible for having the IND approved by the FDA by the application submission deadline. If the intervention is a device that requires an Investigational Device Exemption (IDE) under 21 CFR 812, the IDE must likewise be approved by the deadline. If an IND or IDE is not required, the applicant must provide documentation from the Institutional Review Board (IRB) of record or the FDA supporting that determination. The DoD also notes it can withdraw funding if an IND or IDE is needed but not approved in time, which signals that proposals need to be close to trial-ready rather than exploratory.
Operational feasibility and execution planning are also central review themes. The trial is expected to start within 12 months of the award date, so applicants need realistic startup timelines, site readiness, and a clear plan to recruit participants. Applications must lay out quarterly enrollment targets across all sites in the Statement of Work, and awardees will be expected to agree on formal recruitment milestones with USAMRAA. Continued funding is tied to adequate progress against those recruitment benchmarks, which effectively makes accrual performance a major condition of ongoing support.
The announcement spells out what a strong application should contain from a scientific and clinical-trial design standpoint. Applicants must include preliminary data relevant to the proposed trial and show a solid scientific rationale grounded in logical reasoning and a critical reading of the literature. The protocol should be built around Good Clinical Practice expectations, with clearly defined objectives and endpoints, an explicit statistical analysis plan, and a power analysis that supports the proposed sample size. They also expect applicants to have appropriate statistical expertise on the team, along with a detailed data management plan that protects data integrity. For FDA-regulated trials, the database needs to be compliant with 21 CFR Part 11 and aligned with appropriate data standards.
Safety and quality oversight requirements are treated as non-negotiable trial essentials. Applications are expected to include a safety management plan describing how pharmacovigilance and safety reporting will work, and a clinical monitoring plan describing how compliance with Good Clinical Practice will be monitored. The program also expects a capable study coordinator function to manage IRB submissions, coordinate across participating sites, and support participant accrual. In addition, the applicant must show they have access to a suitable patient population and explain how accrual goals will be met given real-world standards of care that may affect eligibility and enrollment.
The award requires concrete proof that the intervention can actually be used for the duration of the study, including documented availability of the drug, device, or other materials. The product quality and stability should be documented in a manner consistent with FDA manufacturing expectations relevant to the product type and development phase (for example, GMP and Quality System Regulation concepts). At the same time, the opportunity explicitly restricts the use of award funds for producing or acquiring the intervention itself, such as purchasing the product from a manufacturer, so applicants need to have a credible supply plan that does not rely on this award to buy the investigational product.
A practical commercialization and next-steps mindset is built into the requirements. Applicants are encouraged to describe the planned labeled indication, when appropriate, and to outline a product development plan that supports that intended use. They must also include a Transition Plan explaining how the intervention will move into the next clinical phase and/or toward market delivery if the study is successful, including likely resources and future funding. The application should also reflect the team’s experience working with the FDA, including prior submissions when applicable, and should demonstrate strong institutional support, including willingness to serve as the FDA regulatory sponsor when needed and to fulfill sponsor responsibilities outlined in 21 CFR 312 Subpart D.
There are also transparency and public reporting obligations. Funded trials must register on ClinicalTrials.gov before the study begins. They are also required to post the informed consent form used to enroll subjects on a publicly available federal website consistent with federal human research protections requirements (referenced as 32 CFR 219). These requirements underscore that the program is funding trials that are intended to be run to modern compliance and reporting standards, not informal pilot studies.
From an administrative and funding standpoint, awards are issued as assistance agreements, which may be structured as either grants or cooperative agreements depending on how much involvement the DoD anticipates during performance. The administering organization is the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under CFDA 12.420. Eligibility is listed as unrestricted, meaning a wide range of entity types can apply unless additional eligibility notes in the full announcement narrow it. The anticipated maximum direct costs for the full performance period are capped at $2.0 million, with an expectation of roughly three awards. The original posting date was April 7, 2020, with an original closing date of July 16, 2020, and awards anticipated by no later than September 30, 2021.
Finally, the opportunity aligns itself with broader federal priorities around advanced and metastatic disease. It references the Congressionally mandated Metastatic Cancer Task Force and encourages applicants to consider those recommendations when developing ideas, as long as the work fits the PCRP priorities and this specific mechanism’s limits. Overall, the Clinical Trial Award is built for teams that already have a strong scientific premise and enough groundwork in place to launch an early-phase prostate cancer clinical trial quickly, run it rigorously, and produce results that can credibly justify a larger follow-on study.Apply for W81XWH 20 PCRP CTA
- The Department of Defense, 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, Clinical Trial Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Apr 07, 2020.
- Applicants must submit their applications by Jul 16, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 3 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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FY20 DoD Prostate Cancer Research Program (PCRP) Clinical Trial Award - FAQs
What is the main purpose of the FY20 PCRP Clinical Trial Award?
The award is meant to speed up the development of new ways to reduce the burden of prostate cancer by funding early-stage clinical testing in people. It prioritizes trials that can launch quickly, run efficiently, and generate results strong enough to justify larger, later-stage efficacy trials that could ultimately change prostate cancer care and improve outcomes such as survival and quality of life.
What kinds of clinical trials does this award support?
The opportunity focuses on rapid launch and execution of early-phase trials, including Phase 0, Phase I, and pilot Phase II studies. It also supports early clinical studies designed to identify the right patient population for future trials, establish dose and delivery strategies, test feasibility in prostate cancer settings, and evaluate early signals of efficacy and safety.
Does the project have to include a clinical trial?
Yes. This mechanism must fund an actual clinical trial and cannot be used for preclinical work.
How does this funding opportunity define a "clinical trial"?
It uses the standard federal definition: a research study in which one or more human subjects are prospectively assigned to one or more interventions (including placebo or control, if relevant) to measure the effects on biomedical or behavioral health-related outcomes.
Are preclinical studies allowed under this award?
No. The announcement states the award cannot be used for preclinical work.
What types of interventions can be tested?
Interventions are broadly defined and may include drugs, devices, biologics, targeted radionuclides, surgical approaches, behavior-change interventions, or other strategies that can be justified by the investigators.
Can the trial test a repurposed intervention, or does it need to be brand new?
Either is allowed. Projects may test brand-new interventions or repurpose existing ones for new prostate cancer uses, as long as the approach is hypothesis-driven and positioned to make a major impact on one or more of the program's FY20 PCRP Overarching Challenges.
What does it mean that the approach must be hypothesis-driven?
The trial needs to be based on a clear scientific hypothesis and rationale, supported by logical reasoning, a critical reading of the literature, and preliminary data relevant to the proposed clinical study.
How quickly must the study start after the award is made?
The trial is expected to start within 12 months of the award date. Applicants are expected to present realistic startup timelines, site readiness, and an executable recruitment plan.
What are the expectations around participant recruitment and enrollment?
Recruitment planning is treated as a central performance issue. Applications must include quarterly enrollment targets across all sites in the Statement of Work. Awardees will be expected to agree to formal recruitment milestones with USAMRAA, and continued funding is tied to adequate progress against those recruitment benchmarks.
What happens if recruitment milestones are not met?
The announcement indicates that continued funding is tied to adequate progress against recruitment benchmarks, meaning accrual performance can directly affect ongoing support.
What regulatory approvals are required for FDA-regulated products (IND/IDE)?
If the intervention is a drug or biologic requiring an Investigational New Drug (IND) application under 21 CFR 312, the IND must be approved by the FDA by the application submission deadline. If the intervention is a device requiring an Investigational Device Exemption (IDE) under 21 CFR 812, the IDE must be approved by the deadline.
What if the applicant believes an IND or IDE is not required?
If an IND or IDE is not required, the applicant must provide documentation from the Institutional Review Board (IRB) of record or the FDA supporting that determination.
Can funding be withdrawn if the IND/IDE is not in place?
Yes. The DoD notes it can withdraw funding if an IND or IDE is needed but not approved in time, reinforcing that proposals must be close to trial-ready rather than exploratory.
What clinical trial design elements are expected in a competitive application?
The application is expected to align with Good Clinical Practice, with clearly defined objectives and endpoints, an explicit statistical analysis plan, and a power analysis supporting the proposed sample size. It should also include preliminary data relevant to the proposed trial and a strong scientific rationale grounded in the literature.
Is statistical expertise required on the project team?
Yes. The program expects applicants to include appropriate statistical expertise and to present a statistical analysis plan and power analysis that support the proposed sample size.
What data management expectations are described?
Applicants are expected to provide a detailed data management plan that protects data integrity. For FDA-regulated trials, the database needs to be compliant with 21 CFR Part 11 and aligned with appropriate data standards.
What safety oversight plans are required?
Applications are expected to include a safety management plan explaining pharmacovigilance and safety reporting, as well as a clinical monitoring plan describing how compliance with Good Clinical Practice will be monitored.
Is a study coordinator function expected?
Yes. The program expects a capable study coordinator function to manage IRB submissions, coordinate across participating sites, and support participant accrual.
Do applicants need to show access to patients?
Yes. The applicant must demonstrate access to a suitable patient population and explain how accrual goals will be met, including consideration of real-world standards of care that may affect eligibility and enrollment.
Do applicants need to document the availability of the investigational product or intervention materials?
Yes. The award requires concrete proof that the intervention can be used for the duration of the study, including documented availability of the drug, device, or other materials. Product quality and stability should be documented in a manner consistent with FDA manufacturing expectations relevant to the product type and development phase.
Can award funds be used to produce or buy the drug/device/intervention being tested?
No. The opportunity explicitly restricts the use of award funds for producing or acquiring the intervention itself (for example, purchasing the product from a manufacturer). Applicants therefore need a credible supply plan that does not rely on this award to buy the investigational product.
What is the "Transition Plan" and why is it required?
The application must include a Transition Plan describing how the intervention will move into the next clinical phase and/or toward market delivery if the study is successful. This includes identifying likely resources and future funding needed to support the next steps.
Is commercialization or a product development mindset expected?
Yes. Applicants are encouraged to describe the planned labeled indication when appropriate and to outline a product development plan supporting that intended use, alongside the required Transition Plan.
Does the program care about prior FDA experience?
Yes. The application should reflect the team’s experience working with the FDA, including prior submissions when applicable, and demonstrate strong institutional support for regulatory responsibilities.
What sponsor responsibilities may be required for FDA-regulated trials?
The application should show institutional support and willingness to serve as the FDA regulatory sponsor when needed, including fulfilling sponsor responsibilities described in 21 CFR 312 Subpart D.
Are there trial registration and public reporting requirements?
Yes. Funded trials must register on ClinicalTrials.gov before the study begins. They are also required to post the informed consent form used to enroll subjects on a publicly available federal website consistent with federal human research protections requirements (referenced as 32 CFR 219).
What type of funding instrument will be used for awards?
Awards are issued as assistance agreements and may be structured as either grants or cooperative agreements, depending on how much involvement the DoD anticipates during performance.
Who is the administering organization for this opportunity?
The administering organization is the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under CFDA 12.420.
Who is eligible to apply?
Eligibility is listed as unrestricted, meaning a wide range of entity types can apply unless additional eligibility notes in the full announcement narrow it.
What is the maximum funding amount for direct costs?
The anticipated maximum direct costs for the full performance period are capped at $2.0 million.
How many awards are expected to be made?
The announcement states an expectation of roughly three awards.
What are the key dates mentioned in the opportunity?
The original posting date was April 7, 2020. The original closing date was July 16, 2020. Awards were anticipated by no later than September 30, 2021.
Does the opportunity reference any broader federal priorities?
Yes. It references the Congressionally mandated Metastatic Cancer Task Force and encourages applicants to consider those recommendations as long as the proposed work fits PCRP priorities and this mechanism’s limits.
What kind of outcomes is the program ultimately trying to influence?
While the funded work is early-stage, the intent is to generate credible results that can propel later-stage efficacy trials and ultimately improve real-world prostate cancer care, including outcomes such as survival and quality of life.
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