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. 2022 Aug 3;10(8):1872. doi: 10.3390/biomedicines10081872

Table 1.

FDA-approved therapies for prostate cancer.

Drug Class Therapy Indication Clinical
Trial
Efficacy
(Mon.)
Impact on PCa Treatment Reference
2nd-generation antiandrogen Enzalutamide mCRPC AFFIRM OS 18.4 vs. 13.6 ENZ improves OS
after chemotherapy
[14]
PREVAIL OS 35.3 vs. 31.3 ENZ improves OS in
chemotherapy naïve
[15,16]
nmCRPC PROSPER MFS 36.6 vs. 14.7 ENZ decreases the risk of metastasis [17]
mCSPC ENZEMET 80% vs. 72%
(3-year OS)
ENZ improves OS and decreases disease progression [18]
ARCHES rPFS
NR vs. 19.0
ENZ decreases the risk of metastatic progression [19]
Apalutamide nmCRPC SPARTAN MFS 40.5 vs. 16.2 APA decreasse the risk of metastasis [20]
mCSPC TITAN 2-year OS
82.4 vs. 73.5
APA improves OS and PFS [21]
Darolutamide nmCRPC ARAMIS MFS 40.4 vs. 18.4 DA decreases the risk of metastasis [22]
Abiraterone mCRPC COA-301 OS 15.8 vs. 11.2 AB improves OS
after chemotherapy
[23]
COA-302 OS 34.7 vs. 30.3 AB improves OS in
chemotherapy naïve
[24]
High-volume CSPC LATITUDE OS 53.3 vs. 36.5 AB improves OS in
high-risk CSPC
[25,26]
Radiotherapy Radium 223 CRPC with symptomatic bone metastasis, no visceral metastasis ALSYMPCA OS 14.9 vs. 11.3 RA-223 improves OS in symptomatic bony metastatic mCRPC [27]
177Lu-PSMA 617 PSMA-positive mCRPC and already treated with ARB and chemotherapy VISION OS 15.3 vs. 11.3
rPFS 8.7 vs. 3.4
177Lu-PSMA 617 improves OS and rPFS in PSMA-positive mCRPC [28]
Immunotherapy Sipuleucel-T mCRPC IMPACT OS 25.8 vs. 21.7 Sipuleucel-T improves OS in mCRPC [29]
PARP-I Olaparib mCRPC with HRR genes mutation after ENZ or AB PROfound OS 18.5 vs.15.1
rPFS 7.4 cs. 3.6
Olaparib improves OS and rPFS in mCRPC with HRR gene mutation [30]
Rubraca mCRPC with BRCA genes after ARB or chemotherapy TRITON2
(phase2)
TRITON3
(phase3)
ORR 43.5% (IRR)
PSA response rate 54.8%
Rubraca has the antitumor activity in mCRPC with BRCA gene mutation [31,32]

PCa = prostate cancer; nmCRPC = non-metastatic castration-resistant prostate cancer; mCSPC = metastatic castration-sensitive prostate cancer; mCRPC = metastatic castration-resistant prostate cancer; OS = overall survival; rPFS = Radiographic progression-free survival; FDA = Food and Drug Administration; ENZ = Enzalutamide; APA = Apalutamide; DA = Darolutamide; AB = Abiraterone; MFS = metastatic-free survival; NR = non-reached; RA-223 = Radium 223; ARB = androgen receptor blocker; HRR = homologous recombination repair; ORR = objective response rate; IRR = independent radiology review; PARP-I = Polyadenosine diphosphate ribose polymerase inhibitors.