DoD Prostate Cancer Clinical Trial Award Opportunity

The intent of the FY20 PCRP Clinical Trial Award is to accelerate the development of new

interventions to decrease the burden of prostate cancer by supporting the rapid implementation of

early-phase clinical trials (e.g., Phase 0, Phase I, pilot Phase II). Therapeutic approaches

proposed for testing through the Clinical Trial Award may include novel interventions or the

testing of existing interventions for new indications in prostate cancer, but must represent

hypothesis-based approaches for the treatment of prostate cancer that will have a major impact on

one or more of the FY20 PCRP Overarching Challenges. Interventions may include drugs, devices,

biologics, targeted radionuclides, surgical procedures, behavior modifications, or other types of

interventions based on investigator discretion. It is anticipated that outcomes from studies funded

by this award will provide scientific rationale for subsequent development of larger,

efficacy-based clinical trials of interventions that will transform prostate cancer patient care.

Funding from this award mechanism must support a clinical trial and may not be used for preclinical

research studies. A clinical trial is defined as a research study in which one or more human

subjects are prospectively assigned to one or more interventions (which may include placebo or

other control) to evaluate the effects of the interventions on biomedical or behavioral

health-related outcomes. For more information, a Human Subject Resource Document is provided at

https://ebrap.org/eBRAP/public/Program.htm. Examples of acceptable studies

include, but are not limited to, the following:

• Studies designed to identify an appropriate population or subpopulation for future clinical

trials

•   Identification of the dosage, duration, and/or delivery strategy of an intervention

•   Evaluation of the feasibility of the intervention in prostate cancer

•   Evaluation of efficacy and safety of the intervention

Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational

New Drug (IND) application to the FDA that meets all requirements under the Code of Federal

Regulations, Title 21, Part 312 (21 CFR 312) may be required. It is the responsibility of the

applicant to provide evidence from the Institutional Review Board (IRB) of record or the FDA if an

IND is not required. If an IND is required, the IND application must be approved by the FDA by the

FY20 PCRP Clinical Trial Award application submission deadline. The IND should be specific for the

product (i.e., the product should not represent a derivative or alternate version of the

investigational agent described in the IND application) and indication to be tested in the proposed

clinical trial. For more information on IND applications, the FDA has provided guidance at

https://www.fda.gov/drugs/developmentapprovalprocess/

howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/

default.htm.

If the investigational product is a device, then an Investigational Device Exemption (IDE)

application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the

responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is

not required or if the device qualifies for an abbreviated IDE. If an IDE is required, the IDE

application must be approved by the FDA by the FY20 PCRP Clinical Trial Award application

submission deadline. The IDE should be specific for the device (i.e., should not represent a

derivative or modified version of the device described in the IDE application) and indication to

be tested in the proposed clinical trial.

Refer to Attachment 10, Regulatory Strategy, for additional details on documentation of FDA

applications. The Government reserves the right to withdraw funding if an IND or IDE is necessary

but has not been approved prior to the application submission deadline.

Recruitment Milestones: The application must indicate the quarterly enrollment targets across all

sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to

establish milestones for human subject recruitment. Continued support for the project will be based

upon satisfactory progress in meeting the established milestones.

The following are important aspects of the FY20 PCRP Clinical Trial Award:

• The proposed clinical trial is expected to begin no later than 12 months after the award date.

• The proposed intervention(s) to be tested should offer significant potential impact on the lives

and health of individuals with prostate cancer within the context of the FY20 PCRP Overarching

Challenges and should improve patients’ outcomes (longevity, quality of life, etc.) relative to

existing treatments and/or standard of care.

•   Inclusion of preliminary data relevant to the proposed clinical trial is required.

•   The proposed clinical trial must be based on sound scientific rationale that is established

through logical reasoning and critical review and analysis of the relevant literature.

• The application should describe the planned indication for the product label, if appropriate, and

include an outline of the product development plan required to support that indication.

• The application should demonstrate availability of and access to a suitable patient population

that will support a meaningful outcome for the study. The application should include a discussion

of how accrual goals will be achieved and how standards of care may impact the study population.

• The application should demonstrate documented availability of and access to the drug/ compound,

device, and/or other materials needed, as appropriate, for the proposed duration of the study. The

quality and stability of the product should be documented and commensurate with current FDA

manufacturing standards applicable to the type and phase of product being developed (i.e., Quality

System Regulation, Good Manufacturing Practice [GMP] guidelines). Funds from this award may not be

used to support costs associated with producing or acquiring the specified intervention (i.e.

purchasing from the manufacturer).

• The application should reflect the study team’s experience interacting with the FDA, including

previous FDA submissions, if applicable.

• The proposed clinical trial design should include clearly Good Clinical Practice (GCP)- defined

objectives and appropriate endpoints/outcome measures and comply with current guidelines.

• The application should include a clearly articulated statistical analysis plan and appropriate

statistical expertise on the research team, as well as a power analysis reflecting sample size

projections that will answer the objectives of the study.

• The application should include a clearly articulated data management plan and use of an

appropriate database to safeguard and maintain the integrity of the data. If FDA-regulated, the

trial must use a 21 CFR 11-compliant database and appropriate data standards. For more on data

standards, see https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/

FormsSubmissionRequirements/ElectronicSubmissions/UCM511237.pdf.

• The application should include a clearly articulated safety management plan outlining how safety

pharmacovigilance will be conducted, as applicable.

• The application should include a clearly articulated clinical monitoring plan outlining how the

study will be monitored for GCP compliance.

• The application should include a study coordinator(s) who will guide the clinical protocol

through the local IRB of record and other Federal agency regulatory approval processes, coordinate

activities from all sites participating in the trial, and coordinate participant accrual.

• The application should include a Transition Plan (including potential funding and resources)

showing how the product will progress to the next clinical trial phase and/or delivery to the

market after the successful completion of the FY20 PCRP Clinical Trial Award.

• The application should clearly demonstrate strong institutional support and, if applicable, a

commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described

in 21 CFR 312, Subpart D, are fulfilled.

• Funded trials are required to post a copy of the informed consent form used to enroll subjects on

a publicly available Federal website in accordance with Federal requirements described in 32 CFR

219.

• Funded studies are required to register the study in the National Institutes of Health (NIH)

clinical trials registry (www.clinicaltrials.gov) prior to initiation of the study. Refer to the

General Application Instructions, Appendix 1, Section D, for further details.

A Congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying

ways to help accelerate clinical and translational research aimed at extending the lives of

advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP

encourages applicants to review the recommendations

(https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-

Research) and submit research ideas to address these recommendations provided they are within the

limitations of this funding opportunity and fit within the FY20 PCRP priorities.

The types of awards made under the Program Announcement will be assistance agreements. An

assistance agreement is appropriate when the Federal Government transfers a “thing of value” to a

“state, local government,” or “other recipient” to carry out a public purpose of support or

stimulation authorized by a law of the United States instead of acquiring property or service for

the direct benefit and use of the U.S. Government. An assistance agreement can take the form of a

grant or cooperative agreement. The level of involvement on the part of the Department of Defense

(DoD) during project performance is the key factor in determining whether to award a grant or

cooperative agreement. If “no substantial involvement” on the part of the funding agency is

anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on

the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305),

and the award will identify the specific substantial involvement.

Substantial involvement may include, but is not limited to, collaboration, participation, or

intervention in the research to be performed under the award. The award type, along with the start

date, will be determined during the negotiation process.

The anticipated direct costs budgeted for the entire period of performance for an FY20 PCRP

Clinical Trial Award will not exceed $2.0M. Refer to Section II.D.5, Funding Restrictions, for

detailed funding information.

Awards will be made no later than September 30, 2021. 

For additional information refer to Section II.F.1, Federal Award Notices.