Sec. 703. Prostate research, imaging, and men’s education (PRIME)
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This section may be cited as the or the Prostate Research, Imaging, and Men’s Education Act of 2020 . PRIME Act of 2020 Congress makes the following findings: Prostate cancer has reached epidemic proportions, particularly among African-American men, and strikes and kills men in numbers comparable to the number of women who lose their lives from breast cancer. Life-saving breakthroughs in screening, diagnosis, and treatment of breast cancer resulted from the development of advanced imaging technologies led by the Federal Government.
Men should have accurate and affordable prostate cancer screening exams and minimally invasive treatment tools, similar to what women have for breast cancer. While it is important for men to take advantage of current prostate cancer screening techniques, a recent NCI-funded study demonstrated that the most common available methods of detecting prostate cancer (PSA blood test and physical exams) are not foolproof, causing numerous false alarms and false reassurances. The absence of advanced imaging technologies for prostate cancer causes the lack of accurate information critical for clinical decisions, resulting in missed cancers and lost lives, as well as unnecessary and costly medical procedures, with related complications.
With prostate imaging tools, men and their families would face less physical, psychological, financial, and emotional trauma and billions of dollars could be saved in private and public health care systems. The Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Director of the National Institutes of Health and the Administrator of the Health Resources and Services Administration, and in consultation with the Secretary of Defense, shall carry out a program to expand and intensify research to develop innovative advanced imaging technologies for prostate cancer detection, diagnosis, and treatment comparable to state-of-the-art mammography technologies.
In implementing the program under paragraph (1), the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a grant program to encourage the early stages of research in prostate imaging to develop and implement new ideas, proof of concepts, and pilot studies for high-risk technologic innovation in prostate cancer imaging that would have a high potential impact for improving patient care, including individualized care, quality of life, and cost-effectiveness.
In implementing the program under paragraph (1), the Secretary, acting through the Director of the National Institutes of Health, shall utilize the National Institute of Biomedical Imaging and Bioengineering and the National Cancer Institute for advanced stages of research in prostate imaging, including technology development and clinical trials for projects determined by the Secretary to have demonstrated promising preliminary results and proof of concept. In developing the program under paragraph (1), the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish interdisciplinary private-public partnerships to develop and implement research strategies for expedited innovation in imaging and image-guided treatment and to conduct such research.
In developing the program under paragraph (1), the Secretary shall recognize and address— the racial disparities in the incidences of prostate cancer and mortality rates with respect to such disease; and any barriers in access to care and participation in clinical trials that are specific to racial minorities. Subject to subparagraph (B), there is authorized to be appropriated to carry out this section, $100,000,000 for each of the fiscal years 2021 through 2025. Of the amount authorized to be appropriated under subparagraph
(A)for each of the fiscal years described in such subparagraph— no less than 10 percent may be appropriated to carry out the grant program under paragraph (2); and no more than 1 percent may be appropriated to carry out paragraph (4). The Secretary shall carry out a national campaign to increase the awareness and knowledge of individuals in the United States with respect to the need for prostate cancer screening and for improved detection technologies. The national campaign conducted under this subsection shall include— roles for the Health Resources Services Administration, the Office of Minority Health of the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the Office of Minority Health and Health Equity of the Centers for Disease Control and Prevention; and the development and distribution of written educational materials, and the development and placing of public service announcements, that are intended to encourage men to seek prostate cancer screening and to create awareness of the need for improved imaging technologies for prostate cancer screening and diagnosis, including in vitro blood testing and imaging technologies. In developing the national campaign under paragraph (1), the Secretary shall recognize and address— the racial disparities in the incidences of prostate cancer and mortality rates with respect to such disease; and any barriers in access to care and participation in clinical trials that are specific to racial minorities. The Secretary shall establish a program to award grants to nonprofit private entities to enable such entities to test alternative outreach and education strategies to increase the awareness and knowledge of individuals in the United States with respect to the need for prostate cancer screening and improved imaging technologies. There is authorized to be appropriated to carry out this section, $10,000,000 for each of fiscal years 2021 through 2025. The Secretary, in coordination with the Secretary of Defense, shall carry out research to develop an improved prostate cancer screening blood test using in-vitro detection. There is authorized to be appropriated to carry out this section, $20,000,000 for each of fiscal years 2021 through 2025. Not later than 12 months after the date of the enactment of this Act, the Secretary shall submit to Congress a report that details the strategy of the Secretary for implementing the requirements of this section and the status of such efforts. Not later than 36 months after the date of the enactment of this Act, and annually thereafter, the Secretary shall submit to Congress a report that— describes the research and development and public awareness and education campaigns funded under this section; provides evidence that projects involving high-risk, high impact technologic innovation, proof of concept, and pilot studies are prioritized; provides evidence that the Secretary recognizes and addresses any barriers in access to care and participation in clinical trials that are specific to racial minorities in the implementation of this section; contains assurances that all the other provisions of this section are fully implemented; and certifies compliance with the provisions of this section, or in the case of a Federal agency that has not complied with any of such provisions, an explanation as to such failure to comply.