Breast and prostate cancer are significant causes of morbidity and mor
tality and are very similar in etiology, epidemiology, and modalities
of treatment. Investigational strategies in the prevention of these ma
lignancies also have strong parallels. The National Cancer Institute i
s sponsoring several large scale clinical trials involving hormonal ma
nipulation and cancer prevention. In the Breast Cancer Prevention Tria
l, 16,000 women at high risk for breast cancer are being randomized to
receive the antiestrogen agent tamoxifen or placebo for 5 years in an
effort to determine if breast cancer development can be inhibited. In
a similar trial, the Prostate Cancer Prevention Trial, 18,000 men old
er than 55 years of age will be randomized to receive finasteride, a 5
-alpha-reductase inhibitor, or placebo to determine if inhibition of d
ihydrotestosterone synthesis in the prostate over a prolonged period w
ill lead to a decreased incidence of prostate cancer. Both clinical tr
ials offer the possibility of demonstrating that a hormonal interventi
on can decrease an individual's risk of developing breast or prostate
cancer. They also have the potential of providing critical information
about cancer risk, etiology, screening, and genetics, as well as quan
tifying the risks and benefits of specific preventive interventions.