Prostate cancer prevention agent development: Criteria and pipeline for candidate chemoprevention agents.
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.
Nelson
W G
WG
Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Wilding
G
G
D000726:Androgen Antagonists / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D016588:Anticarcinogenic Agents / Q000627:therapeutic use*; D000975:Antioxidants / Q000627:therapeutic use; D002454:Cell Differentiation / Q000187:drug effects; D002455:Cell Division / Q000187:drug effects; D004341:Drug Evaluation; D020847:Estrogen Receptor Modulators / Q000627:therapeutic use; D018120:Finasteride / Q000627:therapeutic use; D015316:Genetic Therapy; D006133:Growth Substances / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D015398:Signal Transduction / Q000187:drug effects
D000726:Androgen Antagonists; D000894:Anti-Inflammatory Agents, Non-Steroidal; D016588:Anticarcinogenic Agents; D000975:Antioxidants; D020847:Estrogen Receptor Modulators; D006133:Growth Substances; D018120:Finasteride