BETHESDA, MdThe National Institutes of Health has unveiled a
5-year plan that, if fully funded, will nearly quadruple its total
budget for prostate cancer research, from the $113.6 million spent in
fiscal year 1998 to $420.1 million in FY 2003. NIH anticipates
spending $180.3 million on researching the disease this fiscal year,
the first year of the 5-year program, an increase of 58.7% over FY 1998.
Following this plan would ensure the development of new
treatments, new preventives, and new interventions with the potential
to improve, extend, or even save the lives of all men touched by
prostate cancer, NIH said in a new report, Planning for
Prostate Cancer Research.
NIH drafted its plan in response to several requests made by
congressional committees. These included a description of current
prostate cancer research activities and the formulation of a plan,
based on the professional judgment of scientists, that would outline
the research opportunities in prostate cancer over 5 years.
Despite advances over the past decade, our treatments for
prostate cancer are inadequate, the side effects of treatment are
unacceptable, and troubling questions remain about the relative
benefit of early detection of the disease, the report said.
Seventy percent of the plans dollar amount is targeted at
clinical or translational research, the report
notedresearch that will have a direct impact on patients,
survivors, and at-risk men.
An important goal is to ensure that every man with prostate
cancer has access to participation in a clinical trial, NIH
added. Other goals include pursuing the expanding understanding of
prostate cancer at the molecular level to develop drugs that kill
tumor cells but spare surrounding tissue, and to move new drugs from
the laboratory to patients as speedily and efficiently as possible.
The increase in FY 1999 spending for prostate cancer research
generally follows recommendations made in a report by NCIs
Prostate Review Group, which was released last September. The future
lines of research outlined by NIH in its new plan are based on
our assessment of scientific opportunities over the next 5 years
without regard to economic constraints or other competing priorities
of the federal government, the report said.
NCI has already begun implementing its national prostate cancer
research program in three ways:
Linking current and potential prostate cancer researchers to a
menu of new research initiatives, resources, and funding opportunities.
Modifying existing NCI initiatives to tailor them to the prioritized
needs of the prostate cancer research community.
Creating new initiatives to fill in gaps in identified high
priorities. Examples include a new mechanism to rapidly fund new
clinical trials in prostate cancer and a new national prostate cancer
The NIH plan focuses primarily on activities of the National Cancer
Institute, whose current budget of $141.5 million for prostate cancer
research accounts for 78.5% of the total NIH allocation for the
disease in FY 1999. That percentage would rise to 80.9% in 2003, if
the NIH plan is fully funded.
However, the report also discusses prostate cancer-related activities
at eight other NIH components: the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), National Human Genome Research
Institute, National Center for Research Resources, National Institute
of Environmental Health Sciences, National Institute on Aging (NIA),
National Institute of Nursing Research (NINR), National Institute of
Mental Health (NIMH), and National Institute of Deafness and Other
The report summarizes a number of programs related to prostate cancer
that are already underway, including NCIs Cancer Genome Anatomy
Project; 246 NCI-sponsored clinical studies in 1997-1998, including
80 phase III trials; NIDDKs basic and clinical studies of
prostate disorders; NIAs epidemiologic investigations of the
diseases high prevalence in elderly men; NINRs research
on symptom management following prostate cancer surgery, including
incontinence and pain; and NIMHs studies of the effects of
stress and emotion in men with prostate cancer.
The 5-year plan is a framework for research activities rather than a
set of specific study requests. Our professional judgment
report largely describes vehicles that the larger scientific,
clinical, and industrial enterprise would fill with specific ideas,
clinical trials, experiments, and technologies, the report
noted. While some of the initiatives described here are not
specific to prostate cancer, they are so relevant that we included
them, expecting that they will help us answer important prostate
In the report, NCI laid out a series of clinical strategies that it
plans to follow. A new program of research grants, called
QuickTrials, aims to move new ideas for therapeutics into
phase I and II clinical trials more rapidly and efficiently.
NCIs goal is to double or triple the number of patients
participating in these early clinical trials, which would include the
testing of agents not previously used against prostate cancer.
NCIs cancer therapy evaluation program in prostate cancer will
launch a series of drug-discovery studies that focus on molecular
targets important to the cancer process. In FY 1999 alone, NCI
expects to initiate about 35 new phase I and II trials to investigate
promising targets and mechanisms at which to aim therapies. These
include studies of angiogenesis, metastasis, growth factors and their
receptors, and tissue-specific genes that are expressed in prostate
This year, NCI plans to begin several multicenter phase III
prostate-cancer studies that will attempt to optimize hormonal
and chemotherapeutic approaches for the most common clinical
presentations. These include androgen-deprivation adjuvant
therapies after prostatectomy and a comparison of the now-standard 8
weeks of preoperative androgen deprivation vs 28 weeks.
The NCI said that multicenter trials in the future will likely
include chemotherapy for patients with androgen-independent disease
and a comparison of prostatectomy vs brachytherapy in patients with
newly diagnosed localized tumors of normal risk.
In addition, the report said, NCI is re-engineering its
clinical trials program and that it will test new systems for
identifying the best trials, improving trial planning, speeding trial
activation, and improving the availability of trials to patients
throughout the country. Prostate and lung cancers will serve as
the primary diseases for testing the Institutes new planning
and access efforts.
As part of the restructuring of its clinical trials program, NCI is
developing a national cancer informatics operation to improve the
linkage, transfer, and analysis of the cancer-related biomedical
information. The Institute is currently working with CapCure, a
national prostate cancer group, to develop a consensus terminology
for prostate cancer.
A key effort by NCI will seek to determine whether early detection
affects mortality and whether routine screening of asymptomatic men
carries a net benefit. It also aims to identify the effects of early
detection on morbidity, mortality, and patients quality of life.
NCI anticipates increasing the number of investigations of
image-guided therapeutics, which combine high-tech imaging techniques
with high-performance computers to deliver radiation or chemotherapy
precisely to a tumor (see News in Brief, p. 4). These methods
hold great potential for minimizing surgical trauma, shortening
recovery time, and reducing health costs, the report noted.
NCI also envisions a series of new prostate cancer prevention trials,
ranging from small proof-of-principle investigations to large-scale
studies in the general population. The time is ripe for
evaluating a growing list of promising chemopre-ventive agents,
the report said. These agents include pro-apoptotics, signal
transducers, antiangiogenics, isoflavones, differentiating agents,
rational combinations (such as antiandrogens with selenium), and gene