Editing Prostate Cancer: Prevention (section)

=== <span style="color:#ff00ff">Prostate Cancer Prevention Trial (PCPT) (NEJM 2003)</span> ===
*'''<span style="color:#ff0000">Objective: determine whether a 5-ARI could reduce the risk of prostate cancer</span>'''
* '''<span style="color:#ff0000">Population: 18,882 men aged ≥ 55 years with normal DRE and PSA ≤ 3.0ng/ml</span>'''
* '''<span style="color:#ff0000">Randomized to finasteride</span>''' (5mg) '''<span style="color:#ff0000">vs. placebo daily</span>''' 
** '''<span style="color:#ff0000">Biopsy was recommended at the end of the study (7 years) for all participants, or “for cause” in men who had a PSA ≥ 4 ng/ml (adjusted for the effect of finasteride) or an abnormal DRE</span>'''
* '''<span style="color:#ff0000">Primary end point: prevalence of prostate cancer during the 7 years of the study</span>'''
* '''<span style="color:#ff0000">Results:</span>''' 
** 9060 (48%) evaluable for primary end point
** '''<span style="color:#ff0000">Significantly reduced risk of incident prostate cancer with finasteride</span>''' 
***'''<span style="color:#ff0000">Absolute risk reduction: 6%</span>''' (18.4% finasteride vs. 24.4% placebo)
** '''<span style="color:#ff0000">Significant increase biopsy Gleason score 7-10 cancers in finasteride group</span>'''
***'''<span style="color:#ff0000">Absolute risk increase: 15%</span> among those undergoing biopsy''' (37% finasteride vs. 22% placebo)
** '''Apparent increase in high-grade cancers with the use of 5-ARIs does not influence cancer-specific survival''' [https://pubmed.ncbi.nlm.nih.gov/30673548/ Goodman, Phyllis J., et al.] "Long-term effects of finasteride on prostate cancer mortality." New England Journal of Medicine 380.4 (2019): 393-394.
* [https://www.nejm.org/doi/full/10.1056/NEJMoa030660 Thompson, Ian M., et al.] "The influence of finasteride on the development of prostate cancer." New England journal of medicine 349.3 (2003): 215-224.