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.