Release Date:  March 23, 2000

PA Number:  PA-00-080

National Cancer Institute
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Environmental Health Sciences


This Program Announcement (PA) replaces PA-99-055, which was published in the 
NIH Guide on January 29, 1999.


The National Cancer Institute (Divisions of Cancer Control and Population 
Sciences, Cancer Prevention, and Cancer Biology), the National Institute of 
Diabetes and Digestive and Kidney Diseases (Division of Kidney, Urologic, and 
Hematologic Diseases), and the National Institute of Environmental Health 
Sciences (Division of Extramural Research and Training) invite 
investigator-initiated research grant applications of molecular epidemiologic 
studies for advancement in understanding prostate cancer development and 
progression.  The purpose of this initiative is to stimulate development and 
application of biological markers of prostate cancer risk and tumor 
aggressiveness and for utilization in chemoprevention studies.  Of special 
interest are studies of markers to elucidate multiethnic differences in 
prostate cancer susceptibility.
This PA will expire in two years from the first receipt date.  NIH Grants 
policies apply to these awards. 


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 area of cancer. This PA, Molecular 
Epidemiology of Prostate Cancinogenesis, is related the priority area of 
cancer. Potential applicants may obtain a copy of "Healthy People 2010" at


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.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 


Support of this program will be through the National Institutes of Health 
(NIH) individual research project grants (R01).  Responsibility for the 
planning, directing, and execution of the proposed project will be solely 
that of the applicant.  The total project period for an application submitted 
in response to this PA may not exceed 4 years.  Because the nature and scope 
of the research proposed in response to this PA may vary, it is anticipated 
that the size of an award will also vary. 

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at



In the United States, prostate cancer has become the most frequently 
diagnosed neoplasm and the second leading cause of cancer mortality in men 
after lung cancer (SEER Prostate Cancer Trends, 1973-95 at  Its incidence  
rate has continued to increase rapidly during the past two decades, 
especially in men over the age of 50 years, and 184,500 new incident cases 
are expected to be diagnosed in 1998.  Prostate cancer develops more rapidly 
with advancing age than any other form of cancer and with the present trend 
toward an aging population, its impact is a major public health concern.

The etiology of prostate cancer is obscure.  Clues may be derived from 
descriptive epidemiology characterizing the steep slope of incidence with 
advancing years, variation in race-specific and international incidence 
patterns, and high prevalence of latent (clinically silent and histologically 
apparent) carcinoma.  The most compelling hypothesis supports a hormonal 
etiology based on the androgen-dependency of the prostate gland for growth 
and function.  Studies in animal models have demonstrated the role of 
androgens in the induction of prostate cancer.  Moreover, in humans, men 
castrated before puberty do not develop prostate cancer, and prostate cancer 
has responded to estrogen therapy.  Case-control studies of serum 
testosterone and other hormones have thus far, however, reported inconsistent 
results, although it has been reported that populations with high levels of 
serum testosterone have an increased incidence of prostate cancer.  

Past studies of familial aggregation and genetic analyses have indicated a 
heritable component in risk.  Recent investigations have suggested that 
prostate cancer risk is related to certain polymorphic genes that regulate 
androgen metabolism, particularly the androgen receptor (AR) gene, and the 
steroid 5-alpha-reductase type II (SRD5A2) gene.  In addition, there has been 
interest in the cytochrome p450c17alpha (CYP17) gene, which encodes the 
enzyme involved in testosterone biosynthesis, and the 3beta-hydroxysteroid 
dehydrogenase type II (HSD3beta2) gene which encodes enzymes involved in 
metabolism of dihydrotestosterone.  Furthermore, there is some evidence 
relating hereditary prostate cancer to loci on chromosomes 1q and chromosome 
X, while some cases appear to arise in association with familial breast 
cancer in relation to BRCA1 and 2. 

The consistently wide geographic variation in rates as well as results of 
migrant studies suggest a role for environmental factors, including diet and 
nutrition.  African American men have the highest incidence and mortality 
rates in the world, almost 1.5 times higher than among U.S. whites and much 
higher than among African populations.  The incidence varies widely around
the world:  a 65-fold difference exists between countries with the highest 
(blacks in U.S. SEER:  137 per 100,000) and lowest (Shanghai, China:  2 per 
100,000) incidence rates  of prostate cancer.  In addition, immigrants from 
low-risk countries (e.g., China or Japan) experience an increased risk after 
migrating to a high-risk country (e.g., United States).  Evidence from 
case-control and cohort studies has suggested that dietary fat may be 
associated with invasive prostate cancer while certain micronutrients such as 
vitamin D, vitamin E, and selenium may be protective.  The role of other 
environmental exposures (e.g., occupation, ionizing radiation, viruses) is 
inconclusive while the effects of lifestyle factors (e.g., smoking, alcohol 
consumption, sexual behavior, body mass, physical activity, vasectomy) have 
yet to be clarified.

The special characteristic of latent prostatic tumors, detected most often at 
autopsy and estimated to affect one third of all males older than 50 years, 
has remained an enigma in our understanding of the natural history and 
biology of invasive prostate cancer.  Interestingly, there are no clear 
racial or geographic differences in the occurrence of small intraprostatic 
foci of latent cancer, whereas the prevalence of larger focal lesions 
parallels the variations in mortality rates.  It has been hypothesized that 
environmental factors may affect the transition of latent to invasive cancer 
by acting as tumor promoters.  Little is known about the molecular events and 
processes involved in the progressive transition to invasive cancer.  
Although genetic alterations in several chromosomes (e.g., 5, 8, 10, 16, 17, 
18, and 22) have been reported in relation to prostate carcinogenesis, the 
association with tumor initiation and progression remains to be elucidated.

Research Goals and Scope

The purpose of this initiative is to stimulate innovative molecular 
epidemiologic research into the origins and progression of prostate cancer.  
Interdisciplinary collaborations, which may include multicenter study sites 
as well as joint effort between NIH/NCI intramural and extramural scientists, 
are encouraged.  These collaborations may include utilization of shared 
laboratory and specimen resources whenever possible.  Applications will be 
welcomed from investigators who are participating in ongoing collaborative 
organizations such as the George M. O'Brien Kidney and Urologic Research 
Centers, the Specialized Programs of Research Excellence in Prostate Cancer 
(SPORES), the NIEHS Environmental Health Sciences Centers and the General 
Clinical Research Centers (GCRCs).  Proposed research duplicating that which 
is currently supported should not be submitted. Proposals to expand an 
ongoing epidemiologic study by the addition of a laboratory component will be 
considered.  Transitional molecular epidemiology studies characterizing and 
validating biomarkers while determining optimal biological specimens and the 
most suitable procedures for collection, processing, and storage are 
encouraged.  Selected measurements or biomarkers should be relevant to the 
processes of prostate carcinogenesis.  Additionally, the utility of hormonal 
and surrogate or intermediate biomarkers should be demonstrated with an 
evaluation of sensitivity, specificity, intra- and inter-individual 

Investigations in understudied populations and in populations of contrasting 
risk, including those who are residing outside of the U.S., are strongly 
encouraged.  Establishment of cohorts of young and older men for 
participation in longitudinal studies as well as of resources such as 
germline DNA repositories and tumor tissue banks with clinical and 
epidemiologic databases is highly recommended.  There is continued interest 
in ascertainment of high-risk families, particularly African-American, to 
accelerate gene identification and functional research.

This PA invites a range of interdisciplinary investigations, including 
molecular epidemiologic, family, or population-based studies of prostate 
cancer, utilizing available or new/novel biomarkers (e.g., biochemical, 
molecular, cellular, genetic) and sources of specimens (e.g., prostate 
tissue, prostatic fluid, blood components) whenever possible.  Examples of 
topics of interest to the participating NIH institutes include, BUT ARE NOT 
LIMITED TO, the areas listed below.

I.  NCI (in response to relevant recommendations of the NCI Prostate Cancer 
Review Group, a committee of members of the scientific, medical, industrial, 
and advocacy communities with the goal of developing a national plan for 
pursuing scientific opportunities in prostate cancer research; refer to URL 
address: under "What’s New")
o Etiology and tumor progression
- differences in genetic predisposition due to variations (polymorphisms) in 
susceptibility and low-penetrance genes, DNA repair activities, cell cycle 
progression, chromosome sensitivity to mutagens or in hormonal metabolism
- gene-environment interactions for understanding modification of prostate 
cancer risk and influence on tumor progression
- suspected premalignant processes (e.g., morphological changes) as 
independent or joint risk factors with, for example, hormones, nutrition, 
genetic components, exogenous exposures that contribute to the transition 
from latent to invasive cancer
- biologic characteristics in pre-cancerous lesions and tumor, such as 
malignancy associated changes, heterogeneity or clusters of small foci, that 
can better define the natural history of prostate cancer and predict 

o Biomarkers
- assessment and validation of genetic and epigenetic markers that predict 
tumor progression from localized to disseminated prostate cancer
- validation of existing biomarkers of risk (e.g., androgen receptor 
mutations, 5-alpha-reductase isoenzymes, epithelial cell receptors, hormonal 
panels including insulin growth factor) in human populations with 
simultaneous consideration of biological variables (e.g., age, ethnicity, 
genetic predisposition, hormonal profiles, pre-existing disease) and 
lifestyle risk factors
- identification, assessment, and validation of novel biomarkers for early 
detection and diagnosis, including comparison with current indicators such as 
- development and clinical validation of new biological markers associated 
with prostate cancer biology (e.g., apoptosis, cell cycle control) with 
determination of their role in responses to specific forms of systemic 
- development and validation of surrogate markers (e.g., nuclear chromatin 
texture as quantitated by image analysis) that can serve as intermediate 
endpoints for intervention or clinical trials testing preventive modalities
o Diet and lifestyle factors
- identification of dietary nutrients affecting prostate cancer risk and 
mechanisms of action by which risk is altered 
- pilot intervention studies of dietary nutrients (e.g., phytoestrogens, 
micronutrients such as vitamins D and E, lycopene, selenium)
- role of lifestyle factors (e.g., smoking, alcohol intake), occupational and 
environmental exposures (e.g., pesticides, viruses), sexual behavior, 
- effect of dietary intake (e.g., fat, micronutrients such as vitamin D, 
calcium, beta-carotene)  singly and jointly or interacting with endogenous 
parameters (e.g., growth factors, steroid receptors, androgen conjugates)

o Primary prevention
- evaluation, including mechanisms of action and affected stages of 
carcinogenesis and inhibition, of promising preventive agents based on 
selection of tumor characteristics most amenable to preventive strategies
- identification and characterization of suspected premalignant processes 
(e.g., prostatic intraepithelial neoplasia or PIN, dysplasia, atypical 
adenomatous hyperplasia) as potential intermediate markers for intervention 

o Identification of risk factors (e.g., environmental, hormonal, viral 
exposure, sexually transmitted diseases, lifestyle, ethnicity) associated 
with benign prostatic hyperplasia or chronic prostatitis and clarification of 
their possible relationships to the development of prostate cancer

III. NIEHS (reflecting the January 1998 announcement of the Environmental 
Genome Project (EGP) to understand the role of environmental response genes 
on human susceptibility to environmental agents; extensive background 
information on the EGP is available at the  following URL:

o Elucidation of the role of environmental response genes (e.g., genes which 
control the distribution and metabolism of toxicants, genes for DNA repair 
pathways, genes for cell death and differentiation, receptor genes, etc.) in 
the development of prostate cancer 

o Enhanced understanding of the impact of occupational and environmental 
exposures on the risk of prostate cancer including interactions with genetic 

o Exploration and elucidation of the role of timing of environmental 
exposures during critical periods of normal prostate gland development (e.g., 
fetal period, childhood, puberty) relevant to future risk of carcinogenesis 
including, but not limited to: 
(a) cellular, genetic, and hormonal effects of environmental exposures on 
normal and abnormal prostate growth and development, and (b) mechanisms by 
which environmental exposures acting as initiating or promoting agents at 
various time periods affect the risk and latency of prostate cancer 


Awardees under this PA are strongly encouraged to participate in a one-day 
meeting of investigators to be held in Bethesda, Maryland, during the last 
year of the grant.  Program directors from the NCI, NIDDK, and NIEHS will 
coordinate this meeting which will provide the opportunity for principal 
investigators to discuss their proposals and work in progress as well as any 
cross-disciplinary methodological and scientific issues.  Applicants may 
request sufficient funds in the budget to accommodate expenses for one to two 
participants to attend the meeting. 


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 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 
"NIH Guidelines on the 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 in the NIH GUIDE FOR GRANTS AND 
CONTRACTS, Volume 23, Number 11, March 18, 1994 available at the following 
URL address:

Applications received in response to this PA are expected to focus on 
scientific issues related to prostate cancer.  In describing the plan to 
recruit human subjects, investigators may cite a focus on prostate cancer as 
the justification for why women will be excluded.  In this regard applicants 
may use Justification 1 from the policy announcement: the research topic to 
be studied is irrelevant to women.


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research conducted or supported by the 
NIH, unless there are scientific and/or ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects," that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 

Applications received in response to this PA are expected to focus on 
scientific issues related to prostate cancer.  In describing the plan to 
recruit human subjects, investigators may cite a focus on prostate cancer as 
the justification for why children will be excluded.  In this regard 
applicants may use Justification 1 from the policy announcement: the research 
topic to be studied is irrelevant to children.


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 Institute 

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) 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 Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email:  For applicants with Internet access, the 
398 kit may be found at:       

The PA title and number must be typed on line 2 of the face page of the 
application form and the YES box must be marked.

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES below with any questions regarding responsiveness of their proposed 
project to the goals of this PA.



Modular grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year.  (Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.)  The total direct costs must 
be requested in accordance with the program guidelines and the modifications 
made to the standard PHS 398 application instructions described below:

o FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities 
and Administrative (F&A) costs] for the initial budget period.  Items 8a and 
8b should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page (see for sample 
pages.)  At the top of the page, enter the total direct costs requested for 
each year.  This is not a form page.

Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals and organizations with whom consortium 
and contractual arrangements have been made, the percent effort of key 
personnel, and the role on the project.  Indicate whether the collaborating 
institution is domestic or foreign.  The total cost for a consortium/ 
contractual arrangement is included in the overall requested modular direct 
cost amount.  Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested. 

BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual’s qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:

-Complete the educational block at the top of the form page;
-List position(s) and any honors;
-Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
-List selected peer-reviewed publications, with full citations.

CHECKLIST:  This page should be completed and submitted with the application.  
If the F&A rate agreement has been established, indicate the type of 
agreement and the date.  All appropriate exclusions must be identified and 
applied in the calculation of the F&A costs for the initial budget period and 
all future budget years.

Applicants planning to submit an investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended/revised version of 
the preceding grant application types requesting $500,000 or more in direct 
costs for any year are advised that he or she must contact the Institute program 
staff before submitting the application, i.e., as plans for the study are being 
developed.  Furthermore, the application must obtain agreement from the 
Institute staff that the Institute will accept the application for consideration 
for award.  Finally, the applicant must identify, in a cover letter sent with 
the application, the staff member and Institute who agreed to accept assignment 
of the application.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

Submit a signed, typewritten original of the application, including the 
checklist, and five signed, exact, single-sided photocopies, in one package 

6701 ROCKLEDGE DRIVE, ROOM 1040 -  MSC-7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)


Applications will be assigned on the basis of established PHS referral 
guidelines. Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures. As part of the initial merit review, all 
applications will 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 applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
appropriate national advisory council or board.

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.  

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?

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?

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?

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)?

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?

The initial review group will also examine: the appropriateness of the 
proposed project budget and duration; the adequacy of plans to include 
minorities and their subgroups as appropriate for the scientific goals of the 
research and plans for the recruitment and retention of subjects; the 
adequacy of plans to include children as appropriate for the scientific goals 
of the research, or justification for exclusion; the provisions for the 
protection of human and animal subjects; and the safety of the research 


Applications will compete for available funds with all other recommended 
applications. NCI intends to additionally consider meritorious applications 
responding to this PA for funding by exception.  The following will be 
considered in making funding decisions:  quality of the proposed project as 
determined by peer review, availability of funds, and Institute/program 


Inquiries concerning this PA are encouraged, particularly during the planning 
phase of the grant applications.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Kumiko Iwamoto
National Cancer Institute
Executive Plaza North, Suite 535
Bethesda, MD 20892-7395
Telephone:  (301) 435-4911
FAX:  (301) 402-4279

Dr. Leroy Nyberg 
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, Room 6AS-13G
Bethesda, MD 20892
Telephone:  (301) 594-7717
FAX:  (301) 480-3510

Dr. Gwen W. Collman
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone:  (919) 541-4980
FAX:  (919) 541-4937

Direct inquiries regarding fiscal matters to:

William Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD 20892
Telephone:  (301) 496-8796
FAX:  (301) 496-8601

Trude McCain
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, 6AN-44J
Bethesda, MD 20892
Telephone:  (301) 594-8859
FAX:  (301) 480-4237

Dorothy G. Duke
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone:  (919) 541-2749
FAX:  (919) 541-2860


This program is described in the Catalog of Federal Domestic Assistance No. 
93.393, 93.849, and 93.894.  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 Part 74 and 92.  This program is not subject to intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients 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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