Full Text DK-97-008
 
CHRONIC PROSTATITIS COLLABORATIVE CLINICAL STUDIES
 
NIH GUIDE, Volume 26, Number 7, March 7, 1997
 
RFA:  DK-97-008
 
P.T. 34

Keywords: 
  Urogenital System 
  Urology 
  Clinical Medicine, General 

 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  March 17, 1997
Application Receipt Date:  May 14, 1997
 
PURPOSE
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites research project grant (R01) applications for four
collaborating Clinical Research Centers (CRC) and one biostatistical
support center (BSC) to participate in an interactive chronic
prostatitis clinical research group (CPCRG).
 
Chronic prostatitis is a significant problem for many men and their
family members.  A recent NIDDK sponsored workshop on chronic
prostatitis developed a system to classify patients with prostatitis
with each category having distinct diagnostic criteria.  The majority
of patients with prostatitis are in the "chronic category" which is
based upon specific characteristics of the prostatic fluid.
 
The purpose of this Request for Applications (RFA) is to provide
support for investigators to collaboratively study patient
self-reported symptoms and the objective diagnostic findings in men
with chronic prostatitis (i.e., pain or discomfort in the pelvic
area, no demonstrable infection using routine clinical methodology).
Emphasis should be placed on state-of-the-art techniques to
characterize the prostatic secretions of men with chronic
prostatitis. Another area of emphasis is the development and
validation of a survey instrument to assess self-reported severity of
illness in these men.
 
Each participating CRC in collaboration with the other CRCs will
develop and carry out uniform and standardized research protocols to
study the biological characteristics of prostatic fluid in men with
chronic prostatitis in the hopes of better defining the etiology of
this condition.  Prior to conducting such objective laboratory
studies it will be necessary to develop and validate a
symptom/severity questionnaire to characterize the subjective aspects
of the disease.
 
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 RFA,
Chronic Prostatitis Clinical Research Centers, is related to the
priority areas of chronic disabling conditions and clinical
prevention services.  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 superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-512-1800).
 
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.
Applications from minority individuals and women are especially
encouraged.  Foreign institutions must demonstrate special or unique
areas of expertise in order to be considered competitive for an
award.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the NIH grants-in-aid
research project grant (R01) award. Responsibility for the planning,
direction, and execution of the proposed project will be solely that
of the applicant.  Awards will be administered under PHS grants
policy as stated in the PHS Grants Policy Statement.
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or principal investigator should be included
with the application.
 
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all
investigator-initiated applications and will be reviewed according to
the customary peer review procedures.
 
FUNDS AVAILABLE
 
For FY 1997, $1,100,000 will be committed to fund applications
submitted in response to this RFA.  It is anticipated that up to five
awards for Clinical Research Centers (CRC) and one award for a
Biostatistical Support Center (BSC) will be made under this RFA.  The
award for the clinical component of each Clinical Center will not
exceed $140,000 direct costs for the first year (protocol development
phase).  The direct costs awarded for the BSC for the first year
(protocol development phase) will not exceed $180,000 direct costs.
It is anticipated that the length of award for all centers will be
five years.  The anticipated award date is September 30, 1997.
 
The number of awards and level of support provided will be dependant
upon the receipt of a sufficient number of applications of high
scientific merit.  Although this program is provided for in the
financial plans of the NIDDK, awards pursuant to this RFA are
contingent upon the availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Background
 
Chronic prostatitis is a chronic, disabling condition affecting
untold numbers of men of all ages and ethnic origins.  The NIDDK
recently sponsored a workshop that was designed to develop a plan to
standardize and evaluate various methods of diagnosis and treatment
of chronic prostatitis with a long term goal of preventing and
effectively treating this condition.  The workshop classified
prostatitis into four clinical categories.
 
Categories I through III are identified by chronic pain. In addition
to pain, categories I and II are readily diagnosed by the presence of
infection.  In contrast, patients with Category III prostatitis do
not have any demonstrable infection of the prostate as determined by
conventional microbiological techniques.  Abnormalities in the
expressed prostatic secretions (EPS) are the primary objective
feature. Chronic pain remains the primary subjective symptom.  The
majority of patients with prostatitis fall into category III (i.e.,
chronic pain and abnormal EPS).  A copy of this workshop report is
available from the urology program staff listed under INQUIRIES.
 
Objectives and Scope for Clinical Centers
 
The aim of this RFA is to develop an interactive research network of
clinical centers that will validate survey and diagnostic tools which
can be used in standardized clinical study protocols including
clinical trials, of men who fit the criteria of category III chronic
prostatitis (pain or discomfort in the pelvic area, no demonstrable
infection using routine clinical methodology).  The study population
is limited to those men in Category III and, if necessary,
appropriately matched controls.  It is not the purpose of this RFA to
study men with acute and recurrent bacterial prostatitis (using
conventional terminology and diagnostic methodology).
 
A high priority of this RFA is to encourage collaborative studies on
the characteristics of semen and expressed prostatic secretions (EPS)
in men with category III chronic prostatitis and to develop and
validate survey instruments and a symptom index which assess the
severity of illness in these men.
 
Based on the recommendations of the Prostatitis Workshop, it is
anticipated that applicants will propose  multi center protocols to:
 
o  correlate the characteristics of  expressed prostatic secretion
(EPS) and/or seminal fluid evaluation in men with chronic prostatitis
and with severity of illness;
 
o  develop and validate a uniform symptom index for chronic
prostatitis, and
 
o  validate the diagnostic criteria established by the NIDDK workshop
panel.
 
Each of the participating centers will also develop protocols which
will also address some of the other recommendations of the workshop
which include:
 
o  development of a standardized treatment protocol for chronic
prostatitis,
 
o  development and validation of outcome measures for the chronic
prostatitis,
 
o  establishment of the relationship between chronic prostatitis,
other prostate diseases and lower urinary tract symptoms (LUTS), and
the
 
o  development of epidemiological studies.
 
It will be advantageous for clinical centers to demonstrate previous
clinical research experience both in recruiting patients into
clinical studies and in developing and validating diagnostic and
assessment tools.
 
Objectives And Scope For The Biostatistical Support Center:
 
Participating investigators will meet together and develop uniform
study protocols to evaluate seminal fluid and EPS and to develop and
validate a patient self-report symptom questionnaire.  The data
obtained from these linked studies will be sent to a BSC. The
responsibilities of the BSC include, in collaboration with the PIs of
the CRCs, development and writing of protocols for the studies and
manuals of procedures.  The BSC will receive and store all data
generated by the CRCs.  They will be responsible for assessing data
quality, evaluating data collection techniques at the CRCs,
establishing procedures for data transmission for the CRCs to the BSC
and performing appropriate statistical analyses of the data.
 
Study Design and Population
 
It is envisioned that over the five year period of this project,
several multi-center projects that address the important issues
identified during the workshop will be developed and implemented by
all the participating CRCs.  The study population will be enrolled
from persons who present with either a clinical diagnosis or the
symptoms of chronic prostatitis (Category III) as defined within this
RFA.  It is envisioned that this population will encompass a broad
range of age groups and include a significant minority
representation.  It is expected that each Clinical Center would have
the ability to screen enough men to enroll at least 50 patients per
year for three years for enrollment in the various assessment and
outcomes validation protocols.  It is expected that a single CRC may
be participating in more than one validation protocol at the same
time.  The Principal Investigators of each center will have equal
responsibility in developing validation and treatment protocols.  One
of the roles of the network is to develop strategies for rapid
dissemination of validated protocols so they may be utilized by the
entire clinical community.
 
Applicants should propose at least two examples (conducted either
concurrently or sequentially) of protocols requiring multi center
participation.  These are examples which they consider important and
which address the objectives of the RFA.  The proposals should
briefly outline the rationale and background of the proposed studies,
eligibility criteria, and baseline and outcome measures.
 
Budget and Related Items
 
All applications must include in their budget, expenses for three
planning trips to Bethesda each year.  All clinical center
applications must include in their budget the costs of any laboratory
studies which will not be covered by private payment.
 
Applications for the CRCs and the Biostatistical Support Center
should prepare five budget periods of 12 months each.  The budget may
be increased at three percent annually for each of the successive
years.  The awards of these budgets will be subjected to
administrative review annually.
 
Collaborative Organization
 
The Principal Investigator of each Clinical Research Center and the
Principal Investigator of the BSC will meet as an interactive
committee three times in each year of the study.  Collaborative
protocols will be developed by this committee.  Data will be
submitted centrally to the BSC.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF MINORITIES IN CLINICAL RESEARCH
STUDIES
 
For projects involving clinical research, the NIH requires applicants
to give special attention to the inclusion of women and minorities in
study populations. For this application, no comment is necessary
regarding inclusion of women.  However, if minorities are not
included in the study population,  specific justification must be
provided.  Applications must address procedures that will be used to
recruit and maintain minority population members into the study, the
specific minority population that will be accessible for inclusion in
the study, and the approximate percent of minority population that it
is anticipated can be recruited.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by March 17, 1997, 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 subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIDDK staff to estimate potential review
workload and to avoid conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F2 - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8885
FAX:  (301) 480-3505
Email:  HaganA@ep.niddk.nih.gov
 
APPLICATION PROCEDURES
 
The research grant application from PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices for sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC-7910, Bethesda, MD 20892-7910,
telephone 301-435-0714, email: asknih@odrockm1.od.nih.gov.
 
The RFA label available in the PHS 398 (rev. 5/95) must be affixed to
the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee on time for review.  In
addition, the RFA title and number must be typed of line 2 of the
face page of the application form and the YES box must be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
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, two additional copies of the application
must be sent to:
 
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F - MSC 6600
Bethesda, MD  20892-6600
 
Applications must be received by April 17, 1997.  If an application
is received after this date it will be returned to the applicant
without review.  The Division of Research grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review unless the applicant
withdraws the pending application.  The DRG will not accept any
application that is essentially the same as one already reviewed.
 
REVIEW CONSIDERATIONS
 
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 the NIDDK in accordance with 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 will
be discussed, assigned a priority score, and receive a second level
review by the National Diabetes and Digestive and Kidney Disease
Advisory Council.
 
Applicants are encouraged to submit and describe their own ideas on
how best to meet the goals of the study. Applications will be judged
primarily on the scientific quality of the application.  Although the
technical merit of the protocol is important, it will not be the sole
criterion for selection of an application for award. Other
considerations such as the importance and timeliness of the proposed
studies, access to patients including minority populations, the
discussion of considerations relevant to the RFA, expertise of the
investigators, their capability to perform the work proposed, and a
demonstrated willingness to work as part of the network will be part
of the evaluation and funding criteria.
 
The review group will also assess the following:
 
Clinical Centers:
 
o  Scientific merit of the proposed studies;
 
o  Qualifications, experience, and commitment of key personnel
including previous experience in relevant studies;
 
o  Viability of plans to recruit an adequate number of patients,
including an appropriate representation of minorities;
 
o  Facilities, equipment and organizational structure to effectively
implement protocols through the network;
 
o  Rationale and cost-effectiveness of the research approach
proposed.
 
o  Appropriateness of the proposed budget.
 
o  For foreign applicants: opportunities for furthering research
programs through the use of unusual talent resources, populations, or
environmental conditions in other countries that are not readily
available in the United States or which augment existing U.S.
resources
 
Biostatistical Support Center:
 
o  Organizational, administrative, and supervisory ability and
statistical expertise to serve as a Biostatistical Support Center for
the multi center interactive projects;
 
o  Qualifications, experience, and commitment of key personnel;
 
o  Facilities and equipment to function as a Biostatistical Support
Center for an interactive network;
 
o  Cost-effectiveness of procedures proposed;
 
o  Appropriateness of the budget for the work proposed.
 
AWARD CRITERIA
 
Applications recommended by the NIDDK Advisory Council will be
considered for award based upon (a) scientific and technical merit;
(b) program balance, sufficient compatibility of features to make a
successful collaborative program a reasonable likelihood and the
geographic distribution of the participating centers; (c)
availability of funds.
 
The anticipated date of award is September 30, 1997.
 
INQUIRIES
 
Inquiries concerning this RFA are strongly encouraged. The
opportunity to clarify any issues or questions from potential
applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
John W. Kusek, Ph.D. or Leroy M. Nyberg, Ph.D., M.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  KusekJ@ep.niddk.nih.gov
        NybergL@ep.niddk.nih.gov
 
Direct inquiries regarding fiscal and administrative matters to:
 
Ms. Trude Hilliard
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8859
FAX:  (301) 480-3504
Email:  HilliardT@ep.niddk.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849.  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 work place 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, heath 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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