Prostate cancer prevention agent development: Criteria and pipeline for candidate chemoprevention agents

William G Nelson, G. Wilding

Research output: Contribution to journalArticle

Abstract

Epidemiologic data suggest that prostate cancer morbidity and mortality ought to be preventable. New insights into the molecular pathogenesis of prostate cancer offer new opportunities for the discovery of prostate cancer chemoprevention drugs and new challenges for their development. Established pathways that lead to US Food and Drug Administration (FDA) approval of drugs for advanced prostate cancer may not be appropriate for the development of drugs for prostate cancer chemoprevention. For example, large randomized clinical trials designed to test the efficacy of new chemoprevention drugs on prostate cancer survival in the general population are likely to be conducted at great expense and take many years, threatening to increase commercial development risks while decreasing exclusive marketing revenues. As a consequence, to accelerate progress in research, new validated surrogate and strategic clinical trial endpoints, and new clinical trial designs featuring more precisely defined high-risk clinical trial cohorts, are needed. In this review, 10 criteria for prostate cancer chemoprevention agent development are offered and the pipeline of new prostate cancer chemoprevention drug candidates is considered.

Original languageEnglish (US)
Pages (from-to)56-63
Number of pages8
JournalUrology
Volume57
Issue number4
DOIs
StatePublished - 2001

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Chemoprevention
Prostatic Neoplasms
Clinical Trials
Pharmaceutical Preparations
Drug Approval
Marketing
Randomized Controlled Trials
Morbidity
Mortality
Research
Population

ASJC Scopus subject areas

  • Urology

Cite this

Prostate cancer prevention agent development : Criteria and pipeline for candidate chemoprevention agents. / Nelson, William G; Wilding, G.

In: Urology, Vol. 57, No. 4, 2001, p. 56-63.

Research output: Contribution to journalArticle

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