AGING, RACE, AND ETHNICITY IN PROSTATE CANCER Release Date: August 29, 2001 RFA: RFA-AG-02-003 National Institute on Aging (http://www.nih.gov/nia/) Letter of Intent Receipt Date: November 13, 2001 Application Receipt Date: December 12, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS FOR ALL APPLICATIONS SUBMITTED IN RESPONSE TO THIS RFA. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute on Aging invites research applications to expand knowledge on aging- and age-related aspects of prostate cancer in different populations at varying risk for this disease. Prostate cancer is a major age-related malignancy. Seventy-one percent of prostate cancer incidence and 92% of prostate cancer deaths occur in the age group 65 years and older. Older men of all race and ethnic backgrounds are at risk for prostate cancer, however, the burden of this malignancy varies according to age, race, and ethnicity. Among diverse male population groups in the United States, African Americans and Caucasians have the highest prostate cancer incidence and higher mortality rates. By contrast, American males of Asian and Hispanic descent, and American Indians, and Alaska Natives have lower incidence and mortality rates than African Americans and Caucasians. Epidemiologic data describe these differences to a limited extent, but there is a dearth of information on why rates vary so dramatically in prostate cancer risk according to age, race, and ethnicity. Factors accounting for disparities among the diverse population groups and the impact of this malignancy concomitant with aging are unknown. There is a paucity of data available regarding age-related differences on the biologic properties and clinical aspects of prostate cancer among different race/ethnicity populations. The purpose of this RFA is to support research that will provide information leading to better prevention, diagnosis, prognosis, and treatment of prostate cancer in the age range in which prostate cancer most frequently occurs in the diverse population groups at risk (i.e., in men 65 years and older). Proposals to address the issues indicated above may be focused on genetic and environmental risk factors, pre-malignant changes, tumorigenesis, detection of localized and advanced disease, prognostic indicators, disease progression, and response to treatment. Studies to evaluate or refine the ability of existing diagnostic, screening, or follow-up methods of persons of different age, race, and ethnicity are also responsive to this RFA. All proposed studies should address aging- or age-related factors. Comparisons of individuals from two or more population groups are strongly encouraged, but not mandatory. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Aging, Race, and Ethnicity in Prostate Cancer, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 2002. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE For FY 2002, $2,500,000 will be committed by NIA to fund applications submitted in response to this RFA. A total of 5 to 7 meritorious applications will be awarded that are relevant to the NIA mission. Although the financial plans of the Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. The RFA will not be reissued. Direct costs will be awarded in modules of $25,000 up to a maximum of $350,000, less any overlap or other necessary administrative adjustments. Facilities and Administrative costs will be awarded at the negotiated rate. RESEARCH OBJECTIVES Background The National Institute on Aging (NIA) identified prostate cancer as a research priority in its 1997 Program Announcement, Aging, Race, and Ethnicity in Prostate Cancer (PA-97-019), NIH Guide to Grants and Contracts, Volume 25, Number 44. The PA encouraged 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 men of different races and minority backgrounds. The impetus for the earlier program announcement and this RFA is based on the magnitude of prostate cancer in older men as a significant public health problem. This is dramatically indicated by the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) program data, 1994-98. The magnitude of the prostate cancer problem increases with advancing age. Prostate cancer has the highest age-adjusted incidence rates of any malignancy in men 65 years and older, 1457.7 (black males) and 932.2 (white males) per 100,000 population. Age-adjusted incidence rates per 100,000 population for black and white males under age 65 years, by contrast, are 96.4 and 49.4 per 100,000 population, respectively. Peak age-specific incidence rates per 100,000 population for this tumor in African Americans are in the five-year age groups 70-74 years (1747.9) and 75-79 (1562.0) years. Caucasian Americans incidence rates in these same age groups are 70-74 years (1084.0) and 75-79 (1056.8) years. The highest rates of prostate cancer mortality per 100,000 population are in black males aged 80-84 (922.4) and 85+ (1323.8) years. For white males the mortality rates, while also the highest in the 80-84 (403.6) and 85+ (732.8) age groups, are roughly half those for black males. [1] Contributing to the prominence of the prostate cancer problem in older men are two age-relevant demographic phenomena -- extended life expectancy and an overall increase in the U.S. population. Male life expectancy at birth for males has increased from 46.3 years at the beginning of the 20th century to 73 years (2000).[2] The U.S. population is made up of a greater proportion of older men than in previous decades. Over 10% of the current total male population is 65 years and older. By 2030 the percentage is projected to increase to over 18%. In numbers, this represents an increase from over 14 million males 65 years and older in the U.S. population (2000) to a projected 31 million men in this age group by 2030. [3]. Research Goal/Scope The goal of this RFA is to stimulate research that will provide information leading to better diagnosis, prognosis, and treatment of prostate cancer in the age range in which prostate cancer most frequently occurs in the diverse race/ethnicity population groups at risk such as African Americans, Caucasians, Asians, Hispanics, American Indians, and Alaska Natives. These may include studies targeting men of advancing age (among whom prostate cancer rates are highest, but on whom relatively little prostate cancer research has been conducted) and comparative age studies of older men and younger men afflicted with this malignancy. The RFA encourages extension and application of current scientific knowledge and expertise in prostate cancer to age-relevant topics and development of new approaches at the aging/cancer research interface. The studies solicited by this RFA may include exploratory approaches such as primary data collection; secondary analyses of existing data; development or validation of diagnostic methods in different age and ethnic groups; and feasibility testing of recruitment, screening, or patient assessment protocols in different age or ethnic groups. Applicants are encouraged to utilize pertinent existing resources where applicable, such as data or subjects from epidemiologic studies or clinical trials, and prostate and other tissue banks. Targeted areas of research for this RFA solicitation are listed below. While the research categories cover a large variety of scientific areas relevant to aging, race, and/or ethnicity, investigators may suggest related issues for consideration if they meet the two RFA criteria stipulated in the SPECIAL REQUIREMENTS SECTION of this document. o Studies on prostate tumor biology, host response, and tumor progression -- Age-related differences in tumor initiation, progression, and /or development of metastases. -- Variations in tumor cellular and molecular properties in biopsy or surgical specimens related to age, race, and ethnicity and their relationship to tumor progression and metastases. -- Examination of the effects of age-related changes in tumor properties (as distinguished from those of age-related changes in host responses) on tumor initiation, progression, and metastasis. -- Variation in responses of tumor cells from patients of different ages to chemotherapeutic agents or radiation. o Studies (epidemiologic or biologic investigations) on prostate cancer risk factors and carcinogenesis -- Effects of age-related physiologic or pathophysiologic changes (e.g., benign prostatic hypertrophy, prostatic intraepithelial neoplasia (PIN), changes in reproductive hormone levels) on risk for prostate cancer. -- Studies on the malignant potential of genetic changes or biological damage from oxidative processes. -- Effects of known and putative genetic and exogenous factors (e.g., alcohol consumption, smoking), and their interactions, on risk for prostate cancer incidence at different ages in different populations. Studies of these risk and protective factors within ethnic groups at highest risk of the disease are particularly encouraged. -- Age-related cellular and molecular changes in prostate tissue obtained from biopsy, surgical, or autopsy specimens regarding their potential contribution to pre-malignant changes or tumorigenesis. o Studies (epidemiologic or clinical investigations) on prognosis, diagnosis and therapy -- Effects of age as it interacts with race and/or ethnicity or of aging alone on sensitivity, specificity, and prognostic value of screening (e.g., PSA) and diagnostic techniques (e.g., sextant biopsy) and scales (e.g., Gleason score) and their predictive value for treatment responsiveness. This includes testing current values of prognostic indicators (e.g., PSA) to assess age-specificity for achieving efficient early detection of clinically significant cancer in older men (i.e., 70 years and older). -- Effects of patient characteristics (e.g., age-related comorbid conditions, age-related physiologic changes) on tumor progression and response to therapy at different ages, including adverse effects. -- Relationship of age, and age-related conditions and physiologic changes, to efficacy and adverse effects of different prostate cancer treatments. -- Methods to distinguish age-related differences in patients with and without clinically significant prostate cancer (e.g., indolence versus aggressive tumor behavior in the context of the aged host). o Surveillance studies focused on using population-based cancer registries -- Organize and conduct prospective cohort studies of men diagnosed with prostate cancer to include pre-diagnostic information (biopsies, PIN, and pretreatment PSA) and how these data may vary according to age and race and ethnicity or aging alone.-- Evaluate risk for recurrence and metastasis after treatment -- Develop tissue bank resources in association with cancer registration o Follow-up tissue studies of patients on clinical trial prostate cancer protocols to ascertain characteristics of older prostate cancer patients as compared to younger patients and how they vary according to race and/or ethnicity on selected outcomes after treatment. o Studies of prostate cancer of patients across the age spectrum who are of different race and ethnic groups with striking differences in incidence rates according to residence in the same or different geographic areas to identify more specifically the etiologic factors and to study their relationships with biomarkers of exposure. SPECIAL REQUIREMENTS A distinctive feature of this research solicitation is the requirement that proposals test hypotheses about aging, including potential differences among populations that are at disparate risks for prostate cancer. To be responsive to this RFA, an application must meet the following criteria: 1. The proposed study should address the relationship of age- or aging-related factors to prostate cancer risk focusing on one or more of the following -- biologic properties, detection, prognosis, diagnostic accuracy, or treatment efficacy. Examples of types of studies that are encouraged include, but are not limited to: comparisons of persons of different ages, studies of the effects of known age-related changes on prostate cancer risk or outcomes, or studies of factors affecting the rate of progression with age of premalignant changes or prostate cancer risk factors. Studies that do not address age- or aging-related factors will not be considered responsive. Comparisons of individuals from two or more population groups are strongly encouraged, but not mandatory. 2. The research must be focused on human prostate cancer. In vitro studies of human cells or tissues, and xenograft studies of human prostate cancer or normal human prostate tissue in laboratory animals may be proposed. INCLUSION OF MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that members of minority groups and their sub- populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions beginning on page 13 of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, original of the application, including the Checklist, and three signed photocopies of the application in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, send two additional copies of the application to: Mary Nekola, Ph.D. Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 It is important to send these copies at the same time as the original and three copies are sent to the Center for Scientific Review. These copies are used to identify conflicts and to help ensure the appropriate and timely review of the application. Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIA. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIA in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which all applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Aging. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? o The 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. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Schedule: Letter of Intent Receipt Date: November 13, 2001 Application Receipt Date: December 12, 2001 Date of Initial Review: March 2002 Review by Advisory Council: May 2002 Anticipated Award Date: July 2002 AWARD CRITERIA 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 concerning this RFA 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 7201 Wisconsin Avenue, Suite 3E 327 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-5278 FAX: (301) 402-1784 Email: ry3e@NIH.GOV Direct inquiries regarding fiscal matters to: Jean Richelsen 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: richels@mail.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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. REFERENCES 1. Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg LX, Edwards BK (eds), SEER Cancer Statistics Review, 1973-1998, National Cancer Institute, NIH Pub. No. 00-2789, Bethesda, MD, 2000 2. Health, United States, 1999 Health and Aging Chart Book, DHHS Publication Number (PHS) 99 1232-1, Health Status, pp 30-40 3. Day JC, Population Projections of the United States by Age, Sex, and Hispanic Origin: 1995-2050, U.S. Bureau of the Census, Current Population Reports, P25-1130, U.S. Government Printing Office, Washington, DC, 1996


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