Table 1.
Drugs approved for mCRPC by the US food and drug administration
| Drug | Approval Date | Therapy Line and Duration Guidelinea | MOA | Pivotal Trial | |
|---|---|---|---|---|---|
| Pre‐docetaxelb | Post‐docetaxelc | ||||
| Docetaxel | May 2004 | n/a | n/a | Taxane (chemotherapy by tubulin inhibition) | TAX327 5, 6 |
| Sipuleucel‐T | April 2010 | Yesd | Yesd | Autologous cellular immunotherapy | IMPACT 12 |
| Cabazitaxel | June 2010 | No | Yes | Next generation taxane | Tropic 13 |
| Abiraterone acetate | April 2011eDecember 2012e | Yes | Yes | Androgen synthesis inhibitor | COU‐AA‐301 19, 27COU‐AA‐302 28 |
| Enzalutamide | August 2012fSeptember 2014f | Yes | Yes | Androgen receptor antagonist | AFFIRM 20 PREVAIL 29 |
| Radium‐223 | May 2013 | CRPC unfit or declined for docetaxel | Yesg | Bone‐directed alpha‐emitting radionuclide | ALSYMPCA 14 |
CRPC, castration‐resistant prostate cancer; MOA, mechanism of action; mCRPC, metastatic CRPC; n/a, not applicable.
a
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 1.2016 30.
b
Asymptomatic.
c
Symptomatic.
d
Asymptomatic/minimally symptomatic, no visceral disease, good performance status.
e
Approved in 2011 for the treatment of mCRPC post‐docetaxel; approval expanded in 2012 to chemotherapy‐naïve mCRPC.
f
Approved in 2012 for the treatment of mCRPC post‐docetaxel; approval expanded in 2014 to chemotherapy‐naïve mCRPC.
g
CRPC patients with symptomatic metastatic bone disease and no known visceral metastases.