Full Text PA-97-019 AGING, RACE, AND ETHNICITY IN PROSTATE CANCER NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PA-97-019 P.T. Keywords: National Institute on Aging National Cancer Institute National Institute of Environmental Health Sciences PURPOSE The National Institute on Aging (NIA), the National Cancer Institute (NCI) and the National Institute of Environmental Health Sciences (NIEHS) invite research grant applications to expand the understanding of biological and clinical factors leading to the development, progression, and treatment of prostate cancer in aging men. The increased risk of prostate cancer with advancing age and its prominence in older-aged men are well known characteristics of this tumor. The unusually high incidence and mortality rates of prostate cancer for older white and black American men and, by contrast, the much lower rates in men of Hispanic and Asian descent, provide the need for research that emphasizes the role of race and ethnic factors, as well as age, in early diagnosis, management, and etiology of this tumor. This Program Announcement is intended to stimulate research that applies the expanding scientific knowledge gained on prostate cancer to older men and to extend the knowledge base on age-related aspects of the etiology of this malignancy. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Aging, Race, and Ethnicity in Prostate Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the research program project or First Independent Research Support and Transition (FIRST) awards (R29). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms of support will be the investigator-initiated research project grant (R01) and FIRST award (R29). RESEARCH OBJECTIVES Background Though investigators acknowledge aging as a high risk factor for prostate cancer, current studies are limited by a lack of attention to the aging process and/or old age in combination with race, and ethnic factors. Further, it is also recognized that black Americans are affected by this tumor to an even greater extent than white Americans and that men of other race or ethnic origin are affected far less. Despite these striking age, race, and ethnic differences, no extensive research focus has been directed toward the role of aging, race, and ethnicity in prostate cancer. The magnitude of the prostate cancer problem for aging men, recent scientific and technologic advancements made relevant to prostate cancer detection and management, and the projected expansion of the aged male population combine to provide the impetus for this research solicitation. Summary Data -- Prostate cancer has the highest incidence of any tumor affecting men in the United States. In 1996, 317,000 new prostate cancer cases will be diagnosed according to estimates made by the American Cancer Society (ACS). Population-based data from the NCI Surveillance, Epidemiology, and End Results (SEER) Program show that the majority (81 percent) of persons affected by prostate cancer are 65 years and older. The median age for this malignancy is 72 years (SEER). Race and ethnic disparities in prostate cancer are portrayed with data collected on newly diagnosed cancers between 1988 and 1992 by the NCI SEER Program showing age-adjusted incidence rates for cancer for men of all ages. The summary incidence rate among black men is 180.6 per 100,000 population as compared to a rate of 134.7 for white men. Rates for men of other race and ethnic backgrounds are much lower: Hispanics, 89.0; Japanese, 88.0; American Indian, 52.5; Alaskan Native, 45.1; Chinese, 46.0; Filipino, 69.8; Hawaiian, 57.2; Vietnamese, 40.0; and Korean, 24.2 (SEER Racial/Ethnic Patterns Monograph). Using age 65 years as a breakpoint, age-adjusted rates per 100,000 population for 1988-1992, show that white men under 65 years have a rate of 32.0 as compared to 48.3 for blacks. For men 65 years and older, the rates are 1120.3 for whites as compared to 1458.9 for blacks. Age-adjusted mortality rates are more than twice as high for blacks as compared to whites for both younger and older age groups. For men under 65 years, the mortality rate for whites is 2.6 as compared to 7.3 for blacks. For men 65 years and older, the rates are 219.7 for whites as compared to 475.6 for blacks (SEER). The overall incidence and mortality rates for black Americans are not only the highest in the United States, they are the highest in the world. Cross-national comparisons with selected industrial nations show that only Sweden has prostate cancer incidence and mortality rates comparable to U.S. whites. Netherlands and Italy follow with rates about half as high as American blacks and whites, respectively. Japan has the lowest prostate cancer incidence and mortality rates of all these countries. Knowledge Development -- Much work has been done to increase the understanding of prostate cancer and great strides have been made in recent years to develop information on effective modalities in early detection and diagnosis of this malignancy. Investigations have explored the relationship between prostatic intraepithelial neoplasia (PIN), a putative precursor lesion to prostate cancer, and the serum marker for prostate cancer known as prostate-specific-antigen (PSA), a screening technique used in combination with other modalities in evaluating men for prostate cancer. Transrectal ultrasound development is another important advancement made in urology techniques that allows characterization of the prostate's normal and abnormal tissue, which when complemented by digital rectal examination (DRE) and PSA, provides valuable information for the detection and study of prostate cancer. Though benefits of different forms of therapy for prostate cancer have not been definitively determined, many investigators continue to address different treatment options that include radical prostatectomy, radiation, and expectant management as the most common therapies. The impact of how aging and concurrent comorbid conditions of the patient with prostate cancer affect treatment decisions and outcomes remain an under investigated area. Demographic Transition -- Unparalleled increases in the aging of the U.S. population impose a considerable public health challenge. The numerical growth of the older-aged male population will increase. Thus, in the future there will be even more older men vulnerable to prostate cancer. The proportion of males in the age segment 65 years and older in the U.S. population currently constitutes 13.9 million. At the beginning of the 21st century (2000), that number is expected to increase to 14.6 million. Fifteen years later, in 2015, 20.0 million of the male population will be in this age group. By 2030, 31.8 million men will be 65 years and older (reflecting the total effects of the "baby boom" phenomenon). Because of population growth alone, there will be even greater numbers of males likely to be affected by prostate cancer. An organized focus to ascertain what transpires at the aging/prostate cancer interface is needed to deal with the current and future problems caused by this malignancy. Research Goals and Scope This PA encourages the extramural research community to take advantage of recently acquired scientific knowledge and expertise developed in biology, gerontology, oncology, urology, and other disciplines and professions and apply these resources to aging relevant research questions on prostate cancer for aging males of different races and minority backgrounds. Major questions on prostate cancer in the context of an aging host invite multidisciplinary research in the areas of early diagnosis, management, and etiology of prostate cancer. Research efforts, single or in combination, focusing on diagnosis, management, and etiology, may be addressed as these areas pertain to aging, race, and/or ethnic groups. The targeted areas of research relevant to this PA are identified below. These are not exclusive and related issues designated by the applicant will be considered. Etiology and Risk Factors o Studies on factors that affect the rate of increase with age in risk for prostate cancer, and/or the rate of development and progression of premalignant changes in prostate tissue, as well as their interaction with familial factors, race, and/or ethnicity; o Epidemiologic studies of age-related familial, genetic, and environmental factors that may affect the age of onset, rate of progression, and duration of survival for prostate cancer; o Interactions of aging and age with prostate cancer risk factors (e.g., relative prominence of various risk factors for onset of prostate cancer at different ages; o Risk factors for occurrence of multiple primary prostate tumors. Disease Progression o Extent to which, and mechanism by which, age-related prostate growth leads to increased incidence of prostate cancer; o Role of other age-related biological factors that lead to the development and affect the progression rate of prostate cancer; o Assessment of protective factors that mitigate against prostate cancer (allow aging without development of premalignant changes); o Metastatic potential of various precursor lesions for prostate cancer in aging men. Diagnosis o Testing of improved methods to identify high risk older white and black men and low risk men of different race and ethnic origin through development of new techniques to distinguish premalignant changes from nonmalignant age-associated changes in prostate tissue; o Validation of new and/or current methodologies or application of current biological, physiological, and clinical techniques to identify high-risk older white and black men [e.g., prostatic intraepithelial neoplasia (PIN) and prostate-specific antigen (PSA)]; o Methods to distinguish older men with "clinically significant" cancer preoperatively; o Verification of diagnostic specificity and predictive value of PSA parameters for older men; o Studies of the causes of racial/ethnic disparities in disease stage at diagnosis (black men present with advanced disease stage more frequently); o Effects of age-associated changes on sensitivity, specificity, prognostic value of diagnostic techniques and their predictive value for response to treatment. Testing new methods and technologies to reduce age-associated problems in diagnosis and prognosis. Management o Testing new interventions or treatment strategies in older men with comorbid conditions to reduce age-associated complications or lessen age-associated reduction in treatment efficacy (as measured by treatment outcomes such as quality of life, functional status, and/or survival experience); o Clinical determinants of age- and ethnicity-associated differences in prostate cancer treatment efficacy and effectiveness for such outcomes as survival, treatment complications, side effects of treatment, and functional status; o Factors responsible for differences among age and ethnic groups in treatment received and clinical outcomes (e.g., stage at diagnosis, presence of comorbid conditions, age selection bias by physicians) and the effects of interactions among such factors. These may address: -- Special features of aging and/or symptoms of illness in old age that influence the treatment and care of older-aged prostate cancer patients and relate to treatment differences or modifications made because of old age; -- Assessment of the effectiveness of different treatments relative to the stage of disease and characteristics of old age (e.g., poor repair mechanisms, functional loss, greater susceptibility to toxicity of treatment); -- Evaluation of tolerance and response to standard or experimental adjuvant radiotherapy regimens or multimodality prostate cancer treatment interventions, controlling for physiologic parameters and other factors; -- Effects of age-associated, cultural, and life-style changes on sensitivity, specificity, prognostic value, and predictive value for treatment responsiveness and diagnostic techniques; -- Effects of previous and/or concurrent illnesses on prostate cancer treatment recommendations. Ancillary Studies/Existing Databases o Ancillary studies conducted with the NCI Clinical Trials Research Cooperative Groups, SEER Special Studies, and population-based tumor registry studies related to aging, race, and ethnicity in prostate cancer are welcome for this research solicitation. These may include studies on barriers to recruitment of older white and black males to prostate cancer clinical trials (e.g., comorbid conditions, physical frailty, lack of transportation), quality of life parameters for cancer patient survival follow-up; o Analyses of existing databases applicable and relevant to addressing treatment of older prostate cancer patients. Emphasis on older ethnic populations that may be compared with white and black populations is encouraged (e.g., longitudinal studies such as the Baltimore Longitudinal Study on Aging; Normative Aging Study; Framingham Study; as well as clinical studies). Research applications require a thorough and detailed explanation of the data elements in the studies identified as candidates for this research solicitation. Special attention should be given to ascertaining biases in the databases. Definitions This PA focuses in particular on men aged 65 years and older because the highest cancer incidence and mortality rates are found in this age group. Also, men in their mid-seventies and older are generally those most severely affected by prostate cancer. These men are also already quite likely to have preexisting chronic conditions which may be problematic in the diagnosis and management of cancer. The definition of "old age" or "elderly," however, is flexible and dependent on investigator-defined parameters. Applicants are expected to identify what is meant by "old" in the context of their research. Age comparisons with younger men are appropriate and may be included. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7762 BETHESDA, MD 20817 (for express/courier service) Receipt dates for new Research Project Grants and FIRST Awards applications are February 1, June 1, and October 1 of each year. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria o Scientific, technical, or medical significance and originality of proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and vertebrate animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rosemary Yancik, Ph.D. Geriatrics Program National Institute on Aging Building 31, Room 5C05 Bethesda, MD 20892 Telephone: (301) 496-5278 FAX: (301) 496-2793 Email: YancikR@31.nia.nih.gov Andrew Chiarodo, Ph.D. Organs System Coordinating Branch National Cancer Institute Executive Plaza North, Room 512 Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 Email: ac53a@nih.gov Gwen Collman, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-4937 Email: collman@niehs.nih.gov Direct inquiries regarding fiscal matters to: Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov Robert E. Hawkins, Jr. Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 213 FAX: (301) 496-8601 Email: HawkinsR@gab.nci.nih.gov David L. Mineo Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 FAX: (919) 541-2860 Email: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research; No. 93.394, Cancer Detection and Diagnosis Research; No. 93.395, Cancer Treatment Research; No. 93.396, Cancer Biology Research; No. 93.399, Cancer Control Research; and No. 93.113, Biological Response to Environmental Health Hazards. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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