Opportunity Information: Apply for W81XWH 19 PCRP CTA
The DoD Prostate Cancer Research Program (PCRP) Clinical Trial Award (CTA) is designed to speed up the testing of promising prostate cancer interventions by funding the rapid launch and execution of early-stage clinical trials, such as Phase 0, Phase I, and pilot Phase II studies. The main goal is to move potential treatments into human testing quickly so the field can generate clear, decision-ready clinical evidence that justifies larger, later-phase efficacy trials. Proposed approaches can be entirely new interventions or existing interventions being repurposed for a new prostate cancer indication, but they must be hypothesis-driven and aimed at making a meaningful dent in one or more of the FY19 PCRP Overarching Challenges, with the expectation that successful results could ultimately change patient care and improve outcomes like survival and quality of life.
A key requirement is that the award must directly support a clinical trial and cannot be used for preclinical research. In this program, a clinical trial is defined as a prospective research study in which one or more human participants are assigned to an intervention (including placebo or other controls when appropriate) to evaluate effects on biomedical or behavioral health outcomes. The announcement highlights several types of trials that fit well, including studies that help identify the right patient population or subpopulation for future trials, determine dose and scheduling or delivery strategies, test feasibility in prostate cancer settings, and evaluate early signals of safety and efficacy. In practical terms, the CTA is meant to fund the kind of rigorous, early human testing that answers, "Is this safe, can we deliver it as intended, who should receive it, and is there enough activity to justify the next step?"
The scope of interventions is intentionally broad. Applicants may propose drugs, devices, biologics, targeted radionuclides, surgical procedures, behavioral modifications, or other interventions, as long as the rationale is strong and the proposed clinical test is appropriate for an early-phase setting. However, the program places heavy emphasis on readiness: applicants are expected to have preliminary data that support the clinical hypothesis and to ground the trial in a sound scientific rationale built from critical analysis of the existing literature and logical reasoning. The application is also expected to describe the planned product label indication when relevant and to outline a credible product development plan that supports that intended indication, signaling that this award is meant to be a step along a realistic translational and regulatory path rather than a stand-alone academic exercise.
Regulatory preparedness is a central feature of this opportunity. If the trial involves a drug that is not FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application may be required, and if an IND is required it must be FDA-approved by the application submission deadline. Similarly, if the investigational product is a device, an Investigational Device Exemption (IDE) may be required, and if so it must also be FDA-approved by the submission deadline. Applicants must provide documentation from the Institutional Review Board (IRB) of record or the FDA when an IND or IDE is not required (or when an abbreviated IDE is applicable). The government also reserves the right to withdraw funding if an IND or IDE is necessary but not in place by the deadline, underscoring that the CTA is for trials that are genuinely ready to start rather than still sorting out core regulatory prerequisites.
The award structure strongly favors studies that can get moving quickly and recruit successfully. Trials are expected to begin no later than 12 months after the award date. Applications must include quarterly enrollment targets across all sites in the Statement of Work, and awardees will work with the U.S. Army Medical Research Acquisition Activity (USAMRAA) to set formal recruitment milestones. Continued funding depends on satisfactory progress toward those accrual milestones, which effectively makes recruitment performance a go/no-go factor during project execution. Applicants also need to convincingly demonstrate access to an appropriate patient population and present a realistic accrual strategy, including discussion of how current standards of care could affect eligibility and enrollment.
Operational quality expectations are detailed and aligned with FDA and Good Clinical Practice (GCP) norms. The application should include clear objectives and endpoints, an appropriate statistical analysis plan with qualified statistical expertise, and a power analysis that ties sample size to the trial objectives. It must also include a data management plan and an appropriate database to protect data integrity; for FDA-regulated work, the database must be 21 CFR Part 11 compliant and should align with relevant electronic submission data standards. Safety oversight is not treated as an afterthought: applicants are expected to provide a safety management plan for pharmacovigilance (as applicable) and a clinical monitoring plan describing how GCP compliance will be ensured. If an IRB determines the study involves greater than minimal risk, the DoD may require an independent research monitor with expertise matched to the identified risks.
Because this is DoD-funded human research, there is an additional human protections layer beyond local ethics review. Any DoD-supported study involving human subjects, human anatomical substances, or human cadavers must be reviewed and approved by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO), before the research can begin. Local IRB approval is not required at the time of application submission, but HRPO review is mandatory and applicants are advised to plan for at least 2 to 3 months for that process, potentially longer for international research. The program also notes that protocols should ideally be written as stand-alone documents specific to the DoD-funded effort, because if a broader protocol includes non-DoD work, HRPO may require review of the entire protocol and may apply DoD requirements across the broader study, which can trigger substantial revisions.
For multi-institutional trials, the announcement pushes applicants toward a well-defined governance and regulatory structure. The application should identify a lead organization responsible for a master protocol and master consent form and serving as the single point of contact for regulatory submissions. A single IRB/ethics committee approach is strongly recommended when feasible, and HRPO must review the master protocol and consent before it is sent to participating sites for their IRB reviews. Multi-site applications must also address communication and data transfer, handling of specimens and imaging products, and they must include an intellectual and material property plan agreed to by all participating institutions.
The program also sets expectations for transparency and trial registration. Funded trials must be registered on ClinicalTrials.gov before initiation, and awardees must post a copy of the informed consent form used to enroll participants on a publicly available federal website, consistent with applicable federal requirements. In addition, applicants are encouraged to align or collaborate with DoD and/or Department of Veterans Affairs research programs where appropriate, and the proposed work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the broader American public. The announcement also flags the Metastatic Cancer Task Force recommendations as a useful reference point for ideas that accelerate progress for advanced and recurrent disease, as long as proposals fit within the PCRP priorities and the award’s early-phase clinical trial scope.
On funding, the anticipated maximum direct costs for the full period of performance are capped at $2,000,000 per award. Overall, the program expected to allocate about $12.8 million total to make roughly four awards, contingent on federal funds availability and the outcomes of scientific and programmatic review. Awards are issued as assistance agreements, meaning either grants or cooperative agreements, depending on the expected level of DoD involvement during performance. Finally, the timeline information in the opportunity indicates it was created May 3, 2019, with an original closing date of July 18, 2019, and awards anticipated no later than September 30, 2020, using FY19 funds that were expected to remain available for use through September 30, 2025.Apply for W81XWH 19 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 May 03, 2019.
- Applicants must submit their applications by Jul 18, 2019. (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 4 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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FAQs: DoD Prostate Cancer Research Program (PCRP) Clinical Trial Award (CTA)
What is the purpose of the PCRP Clinical Trial Award (CTA)?
The CTA is meant to speed up early-stage clinical testing of promising prostate cancer interventions by funding the rapid launch and execution of Phase 0, Phase I, and pilot Phase II clinical trials. The goal is to generate clear, decision-ready clinical evidence that supports whether an intervention should move into larger, later-phase efficacy trials.
What types of clinical trials are supported under this award?
The CTA supports early-stage clinical trials, including Phase 0, Phase I, and pilot Phase II studies. The announcement emphasizes trials that answer early human-testing questions such as safety, feasibility, delivery, dose/schedule, identifying the right patient population, and early signals of efficacy.
Does the award have to directly fund a clinical trial?
Yes. A core requirement is that the award must directly support a clinical trial and cannot be used for preclinical research.
How does the program define a "clinical trial"?
In this program, a clinical trial is defined as a prospective research study in which one or more human participants are assigned to an intervention (including placebo or other controls when appropriate) to evaluate effects on biomedical or behavioral health outcomes.
Can applicants propose a brand-new intervention, or does it have to be an existing treatment?
Either approach may fit. Proposed approaches can be entirely new interventions or existing interventions being repurposed for a new prostate cancer indication, as long as the proposed work is hypothesis-driven and appropriate for early-stage clinical testing.
What disease focus and impact is the CTA trying to achieve?
The CTA is intended to move potential treatments into human testing quickly, so the field can determine whether there is enough clinical activity to justify later-phase trials. Successful results are expected to have potential to change patient care and improve outcomes such as survival and quality of life.
Do proposals need to address specific program challenges or priorities?
Yes. The intervention must be hypothesis-driven and aimed at making a meaningful impact on one or more of the FY19 PCRP Overarching Challenges, with the expectation that success could ultimately improve patient outcomes.
What kinds of interventions are eligible?
The scope is broad. Applicants may propose drugs, devices, biologics, targeted radionuclides, surgical procedures, behavioral modifications, or other interventions, as long as the rationale is strong and the proposed clinical test is appropriate for an early-phase setting.
Is preliminary data required?
The announcement places heavy emphasis on readiness and states that applicants are expected to have preliminary data supporting the clinical hypothesis. Applications should also build the trial rationale from critical analysis of existing literature and logical reasoning.
Does the application need to include a product label indication and development plan?
When relevant, the application is expected to describe the planned product label indication and outline a credible product development plan supporting that intended indication. This reflects the program expectation that the trial is part of a realistic translational and regulatory path.
What are the IND requirements for drug studies?
If the trial involves a drug that is not FDA-approved for the proposed investigational use, an IND may be required. If an IND is required, it must be FDA-approved by the application submission deadline.
What are the IDE requirements for device studies?
If the investigational product is a device, an IDE may be required. If an IDE is required, it must be FDA-approved by the application submission deadline.
What documentation is needed if an IND or IDE is not required?
Applicants must provide documentation from the IRB of record or the FDA when an IND or IDE is not required (or when an abbreviated IDE is applicable).
Can funding be withdrawn if regulatory requirements are not met?
Yes. The government reserves the right to withdraw funding if an IND or IDE is necessary but not in place by the submission deadline. This reflects the CTA focus on trials that are ready to start.
How quickly must the clinical trial begin after an award is made?
Trials are expected to begin no later than 12 months after the award date.
Are enrollment targets and recruitment milestones required?
Yes. Applications must include quarterly enrollment targets across all sites in the Statement of Work. Awardees will also work with the U.S. Army Medical Research Acquisition Activity (USAMRAA) to set formal recruitment milestones.
How does recruitment performance affect continued funding?
Continued funding depends on satisfactory progress toward accrual milestones. Recruitment performance is treated as a go/no-go factor during project execution.
Do applicants need to show access to an appropriate patient population?
Yes. Applicants must convincingly demonstrate access to an appropriate patient population and provide a realistic accrual strategy, including how current standards of care could affect eligibility and enrollment.
What trial design elements are expected in the application?
The application should include clear objectives and endpoints, an appropriate statistical analysis plan with qualified statistical expertise, and a power analysis that ties sample size to the trial objectives.
What data management expectations apply?
The application must include a data management plan and an appropriate database to protect data integrity. For FDA-regulated work, the database must be 21 CFR Part 11 compliant and should align with relevant electronic submission data standards.
What safety oversight plans are expected?
Applicants are expected to include a safety management plan for pharmacovigilance (as applicable) and a clinical monitoring plan describing how Good Clinical Practice (GCP) compliance will be ensured.
When might an independent research monitor be required?
If an IRB determines the study involves greater than minimal risk, the DoD may require an independent research monitor with expertise matched to the identified risks.
Is local IRB approval required at the time of application submission?
No. Local IRB approval is not required at the time of application submission.
What additional DoD human research review is required before research can start?
Any DoD-supported study involving human subjects, human anatomical substances, or human cadavers must be reviewed and approved by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO), before the research can begin.
How long should applicants plan for HRPO review?
Applicants are advised to plan for at least 2 to 3 months for HRPO review, and potentially longer for international research.
Should the protocol be written specifically for the DoD-funded effort?
Ideally, yes. The program notes that protocols should be written as stand-alone documents specific to the DoD-funded effort. If a broader protocol includes non-DoD work, HRPO may require review of the entire protocol and may apply DoD requirements across the broader study, which can trigger substantial revisions.
What governance structure is encouraged for multi-institutional trials?
For multi-institutional trials, the application should identify a lead organization responsible for a master protocol and master consent form and serving as the single point of contact for regulatory submissions.
Is a single IRB approach recommended for multi-site trials?
Yes. A single IRB/ethics committee approach is strongly recommended when feasible.
What is the required order of review for multi-site trials involving HRPO?
HRPO must review the master protocol and consent before those documents are sent to participating sites for their IRB reviews.
What additional operational topics must multi-site applications address?
Multi-site applications must address communication and data transfer, handling of specimens and imaging products, and include an intellectual and material property plan agreed to by all participating institutions.
Are there trial transparency and registration requirements?
Yes. Funded trials must be registered on ClinicalTrials.gov before initiation.
Are there requirements related to posting informed consent forms publicly?
Yes. Awardees must post a copy of the informed consent form used to enroll participants on a publicly available federal website, consistent with applicable federal requirements.
Is collaboration with DoD or the Department of Veterans Affairs encouraged?
Yes. Applicants are encouraged to align or collaborate with DoD and/or Department of Veterans Affairs research programs where appropriate.
Who must the proposed work be relevant to?
The proposed work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the broader American public.
Does the announcement mention any reference framework for metastatic disease research ideas?
Yes. The program flags the Metastatic Cancer Task Force recommendations as a useful reference for ideas that accelerate progress for advanced and recurrent disease, as long as proposals fit PCRP priorities and the award's early-phase clinical trial scope.
What is the maximum funding level for this award?
The anticipated maximum direct costs for the full period of performance are capped at $2,000,000 per award.
How many awards does the program expect to make and what is the total anticipated funding?
The program expected to allocate about $12.8 million total to make roughly four awards, contingent on federal funds availability and the outcomes of scientific and programmatic review.
What type of funding mechanism is used (grant vs cooperative agreement)?
Awards are issued as assistance agreements, meaning either grants or cooperative agreements, depending on the expected level of DoD involvement during performance.
What dates are associated with this opportunity?
The opportunity indicates it was created May 3, 2019, with an original closing date of July 18, 2019. Awards were anticipated no later than September 30, 2020, using FY19 funds expected to remain available through September 30, 2025.
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| DoD Prostate Cancer, Synergistic Population and Data Science Award Apply for W81XWH 19 PCRP SPDSA Funding Number: W81XWH 19 PCRP SPDSA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Health Disparity Research Award Apply for W81XWH 19 PCRP HDRA Funding Number: W81XWH 19 PCRP HDRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lupus, Concept Award Apply for W81XWH 19 LRP CA Funding Number: W81XWH 19 LRP CA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lupus, Impact Award Apply for W81XWH 19 LRP IA Funding Number: W81XWH 19 LRP IA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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| DoD Breast Cancer, Breakthrough Award Levels 1 and 2 Apply for W81XWH 19 BCRP BTA12 2 Funding Number: W81XWH 19 BCRP BTA12 2 Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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| DoD Breast Cancer, Breakthrough Award Level 4 Apply for W81XWH 19 BCRP BTA4 2 Funding Number: W81XWH 19 BCRP BTA4 2 Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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