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. 2023 Jan 20;24(3):2046. doi: 10.3390/ijms24032046

Table 1.

Clinical studies on PI3K/AKT/mTOR pathway inhibitors in PCa.

Target Agent Phase Regimen Study Population Status Clinicaltrial.Gov ID
AKT MK2206 II + Bicalutamide High-Risk of Progression PCa with rising PSA Active, not recruiting NCT01251861
I + hydroxychloroquine Stage IV PCa Active, not recruiting NCT01480154
AZD5363
(Capivasertib)
I + Enzalutamide Advanced Solid Tumors Harboring Mutations in AKT1, AKT2, or AKT3 Active, not recruiting NCT03310541
III + Docetaxel mCRPC Recruiting NCT05348577
II + Abiraterone acetate High Risk Localized PCa With PTEN Loss Not yet recruiting NCT05593497
I/II + Docetaxel/Prednisolone mCRPC Completed NCT02121639
Afuresertib I/II + LAE001/prednisone mCRPC Recruiting NCT04060394
PI3K AZD8186 I + Docetaxel mPCa with PTEN or PIK3CB mutations Active, not recruiting NCT03218826
I + Abiraterone acetate Advanced CRPC Completed NCT01884285
GDC-0068
(Ipatasertib)
I/II + Atezolizumab PTEN-loss CRPC Recruiting NCT03673787
III + Abiraterone acetate and prednisone/prednisolone mCRPC Active, not recruiting NCT03072238
II + Abiraterone acetate and prednisone/prednisolone CRPC previously treated with Docetaxel Completed NCT01485861
I + Rucaparib Advanced PCa Completed NCT03840200
GSK2636771 I + Enzalutamide PTEN(-) mCRPC Completed NCT02215096
BKM120
(Buparlisib)
Ib + Abiraterone acetate CRPC Completed NCT01634061
LY3023414 II + Enzalutamide mCRPC Completed NCT02407054
CYH33 I + Olaparib PCa with DDR and/or PIK3CA mutations Recruiting NCT04586335
mTOR RAD001
(Everolimus)
III Monotherapy CRPC patients with PI3K-AKT-mTOR signaling pathway deficiency Not yet recruiting NCT03580239
II Monotherapy mCRPC Completed NCT00636090
I + Apalutamide mCRPC after treatment with Abiraterone acetate Completed NCT02106507
I + standard radiation therapy PCa with rising PSA following RP Completed NCT01548807
II + Carboplatin/Prednisone mPCa that progressed after docetaxel Completed NCT01051570
I/II + Docetaxel/Prednisone mCRPC Completed NCT00459186
II Monotherapy HRPC Completed NCT00629525
I/II + Docetaxel/Bevacizumab Advanced PCa Completed NCT00574769
CCI-779
(Temsirolimus)
I/II + Cixutumumab mPCa Completed NCT01026623
II + conventional surgery newly diagnosed PCa at high risk of relapse Completed NCT00071968
CC-115 I Monotherapy PCa Completed NCT01353625
MLN0128
(Sepanisertib)
II Monotherapy CRPC Completed NCT02091531
AZD2014 I Monotherapy prior to RP High Risk PCa Completed NCT02064608

(+) indicates co-treatments; ADT: androgen deprivation therapy; CRPC: castration-resistant prostate cancer; HRPC: hormone-resistant prostate cancer; mPCa: metastatic prostate cancer; mCRPC: metastatic castration-resistant prostate cancer; PSA: prostate-specific antigen; RP: radical prostatectomy.