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Current Molecular Pharmacology

Current Molecular Pharmacology

Editor-in-Chief

ISSN (Print): 1874-4672
ISSN (Online): 1874-4702

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General Review Article

Recent Development and Future Prospects of Molecular Targeted Therapy in Prostate Cancer

Author(s): Jinku Zhangorcid of author, Jirui Sunorcid of author, Sahar Bakht and Waseem Hassan*

Volume 15, Issue 1, 2022

Published on: 03 August, 2021

Article ID: e080621193950

Pages: 11

DOI: 10.2174/1874467214666210608141102

Abstract

Prostate cancer (PC) is a rapidly increasing ailment worldwide. The previous decade has observed a rapid advancement in PC therapies that was evident from the number of FDA approvals during this phase. Androgen deprivation therapies (ADT) have traditionally remained a mainstay for the management of PCs, but the past decade has experienced the emergence of newer classes of drugs that can be used with or without the administration of ADT. FDA approved poly (ADP-ribose) polymerase inhibitors (PARPi) such as olaparib and rucaparib after successful clinical trials against gene-mutated metastatic castration-resistant prostate cancer. Furthermore, drugs like apalutamide, darolutamide and enzalutamide with androgen-targeted mechanism of action have manifested superior results in non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration- sensitive prostate cancer (mCSPC), and metastatic castration-resistant prostate cancer (m- CRPC) respectively with or without previously administered docetaxel. Relugolix, an oral gonadotropin- releasing hormone antagonist and a combination of abiraterone acetate plus prednisone were also approved by FDA after a successful trial in advanced PC and mCRPC respectively. This review aims to analyze the FDA-approved agents in PC during last decade and provide a summary of their clinical trials. It also presents an overview of the ongoing progress of prospective molecules still under trial.

Keywords: Prostate cancer, relugolix, apalutamide, darolutamide, enzalutamide, molecular targeted therapy.

Graphical Abstract

Graphical abstract illustrating key findings of the study

[1]
Siegel, R.L.; Miller, K.D.; Jemal, A. Cancer statistics, 2020. CA Cancer J. Clin., 2020, 70(1), 7-30.
[http://dx.doi.org/10.3322/caac.21590] [PMID: 31912902]
[2]
Grozescu, T.; Popa, F. Prostate cancer between prognosis and adequate/proper therapy. J. Med. Life, 2017, 10(1), 5-12.
[PMID: 28255369]
[3]
Gottschalk, A.R.; Roach, M., III The use of hormonal therapy with radiotherapy for prostate cancer: Analysis of prospective randomised trials. Br. J. Cancer, 2004, 90(5), 950-954.
[http://dx.doi.org/10.1038/sj.bjc.6601625] [PMID: 14997188]
[4]
Dai, C.; Heemers, H.; Sharifi, N. Androgen Signaling in Prostate Cancer. Cold Spring Harb. Perspect. Med., 2017, 7(9), a030452.
[http://dx.doi.org/10.1101/cshperspect.a030452] [PMID: 28389515]
[5]
Komura, K.; Sweeney, C. J.; Inamoto, T.; Ibuki, N.; Azuma, H.; Kantoff, P. W. Current treatment strategies for advanced prostate cancer. Int. J. Urol., 2018, 25(3), 220-231.
[http://dx.doi.org/10.1111/iju.13512]
[6]
Abiodun-Ojo, O. A.; Akintayo, A. A.; Akin-Akintayo, O. O.; Tade, F. I.; Nieh, P. T.; Master, V. A.; Alemozaffar, M.; Osunkoya, A. O.; Goodman, M. M.; Fei, B.; Schuster, D.M. (18)f-fluciclovine parameters on targeted prostate biopsy associated with true positivity in recurrent prostate cancer. J. Nucl. Med., 2019, 60(11), 1531-1536.
[http://dx.doi.org/10.2967/jnumed.119.227033] [PMID: 30954940]
[7]
Alemozaffar, M.; Akintayo, A.A.; Abiodun-Ojo, O.A.; Patil, D.; Saeed, F.; Huang, Y.; Osunkoya, A.O.; Goodman, M.M.; Sanda, M.; Schuster, D.M. [18F]Fluciclovine positron emission tomography/computerized tomography for preoperative staging in patients with intermediate to high risk primary prostate cancer. J. Urol., 2020, 204(4), 734-740.
[http://dx.doi.org/10.1097/JU.0000000000001095] [PMID: 32347780]
[8]
Movahedi, P.; Merisaari, H.; Perez, I.M.; Taimen, P.; Kemppainen, J.; Kuisma, A.; Eskola, O.; Teuho, J.; Saunavaara, J.; Pesola, M.; Kähkönen, E.; Ettala, O.; Liimatainen, T.; Pahikkala, T.; Boström, P.; Aronen, H.; Minn, H.; Jambor, I. Prediction of prostate cancer aggressiveness using 18F-Fluciclovine (FACBC) PET and multisequence multiparametric MRI. Sci. Rep., 2020, 10(1), 9407.
[http://dx.doi.org/10.1038/s41598-020-66255-8] [PMID: 32523075]
[9]
Boreta, L.; Gadzinski, A.J.; Wu, S.Y.; Xu, M.; Greene, K.; Quanstrom, K.; Nguyen, H.G.; Carroll, P.R.; Hope, T.A.; Feng, F.Y. Location of recurrence by gallium-68 PSMA-11 PET scan in prostate cancer patients eligible for salvage radiotherapy. Urology, 2019, 129, 165-171.
[http://dx.doi.org/10.1016/j.urology.2018.12.055] [PMID: 30928607]
[10]
Ceci, F.; Castellucci, P.; Graziani, T.; Farolfi, A.; Fonti, C.; Lodi, F.; Fanti, S. 68Ga-PSMA-11 PET/CT in recurrent prostate cancer: Efficacy in different clinical stages of PSA failure after radical therapy. Eur. J. Nucl. Med. Mol. Imaging, 2019, 46(1), 31-39.
[http://dx.doi.org/10.1007/s00259-018-4189-7] [PMID: 30350010]
[11]
Tulsyan, S.; Das, C.J.; Tripathi, M.; Seth, A.; Kumar, R.; Bal, C. Comparison of 68Ga-PSMA PET/CT and multiparametric MRI for staging of high-risk prostate cancer68Ga-PSMA PET and MRI in prostate cancer. Nucl. Med. Commun., 2017, 38(12), 1094-1102.
[http://dx.doi.org/10.1097/MNM.0000000000000749] [PMID: 28957842]
[12]
Hofman, M.S.; Murphy, D.G.; Williams, S.G.; Nzenza, T.; Herschtal, A.; Lourenco, R.A.; Bailey, D.L.; Budd, R.; Hicks, R.J.; Francis, R.J.; Lawrentschuk, N. A prospective randomized multicentre study of the impact of gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging for staging high-risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): Clinical trial protocol. BJU Int., 2018, 122(5), 783-793.
[http://dx.doi.org/10.1111/bju.14374] [PMID: 29726071]
[13]
Lenzo, N.P.; Meyrick, D.; Turner, J.H. Review of gallium-68 psma pet/ct imaging in the management of prostate cancer. Diagnostics (Basel), 2018, 8(1), 16.
[14]
Bailey, J.; Piert, M. Performance of 68Ga-PSMA PET/CT for Prostate cancer management at initial staging and time of biochemical recurrence. Curr. Urol. Rep., 2017, 18(11), 84.
[http://dx.doi.org/10.1007/s11934-017-0736-1] [PMID: 28889366]
[15]
Parent, E. E.; Schuster, D. M. Update on (18)F-Fluciclovine PET for Prostate Cancer Imaging. J Nucl Med., 2018, 59(5), 733-739.
[http://dx.doi.org/10.2967/jnumed.117.204032] [PMID: 29523631]
[16]
Li, R.; Ravizzini, G.C.; Gorin, M.A.; Maurer, T.; Eiber, M.; Cooperberg, M.R.; Alemozzaffar, M.; Tollefson, M.K.; Delacroix, S.E.; Chapin, B.F. The use of PET/CT in prostate cancer. Prostate Cancer Prostatic Dis., 2018, 21(1), 4-21.
[http://dx.doi.org/10.1038/s41391-017-0007-8] [PMID: 29230009]
[17]
FDA FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer (Accessed on January 1, 2021).
[18]
Markham, A. Relugolix: First Global Approval. Drugs, 2019, 79(6), 675-679.
[http://dx.doi.org/10.1007/s40265-019-01105-0] [PMID: 30937733]
[19]
Shore, N.D.; Saad, F.; Cookson, M.S.; George, D.J.; Saltzstein, D.R.; Tutrone, R.; Akaza, H.; Bossi, A.; van Veenhuyzen, D.F.; Selby, B.; Fan, X.; Kang, V.; Walling, J.; Tombal, B. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N. Engl. J. Med., 2020, 382(23), 2187-2196.
[http://dx.doi.org/10.1056/NEJMoa2004325] [PMID: 32469183]
[20]
MacLean, D.B.; Shi, H.; Faessel, H.M.; Saad, F. Medical Castration using the investigational oral GnRH antagonist TAK-385 (Relugolix): Phase 1 study in healthy males. J. Clin. Endocrinol. Metab., 2015, 100(12), 4579-4587.
[http://dx.doi.org/10.1210/jc.2015-2770] [PMID: 26502357]
[21]
FDA FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-olaparib-hrr-gene-mutated-metastatic-castration-resistant-prostate- cancer (Accessed on January 1, 2021).
[22]
Walsh, C.S. Two decades beyond BRCA1/2: Homologous recombination, hereditary cancer risk and a target for ovarian cancer therapy. Gynecol. Oncol., 2015, 137(2), 343-350.
[http://dx.doi.org/10.1016/j.ygyno.2015.02.017] [PMID: 25725131]
[23]
Blackford, A.N.; Jackson, S.P. ATM, ATR, and DNA-PK: The trinity at the heart of the DNA damage response. Mol. Cell, 2017, 66(6), 801-817.
[http://dx.doi.org/10.1016/j.molcel.2017.05.015] [PMID: 28622525]
[24]
Castro, E.; Romero-Laorden, N.; Del Pozo, A.; Lozano, R.; Medina, A.; Puente, J.; Piulats, J.M.; Lorente, D.; Saez, M.I.; Morales-Barrera, R.; Gonzalez-Billalabeitia, E.; Cendón, Y.; García- Carbonero, I.; Borrega, P.; Mendez Vidal, M.J.; Montesa, A.; Nombela, P.; Fernández-Parra, E.; Gonzalez Del Alba, A.; Villa-Guzmán, J.C.; Ibáñez, K.; Rodriguez-Vida, A.; Magraner-Pardo, L.; Perez-Valderrama, B.; Vallespín, E.; Gallardo, E.; Vazquez, S.; Pritchard, C.C.; Lapunzina, P.; Olmos, D. PROREPAIR-B: A Prospective Cohort Study of the Impact of Germline DNA repair mutations on the outcomes of patients with metastatic castration-resistant prostate cancer. J. Clin. Oncol., 2019, 37(6), 490-503.
[http://dx.doi.org/10.1200/JCO.18.00358] [PMID: 30625039]
[25]
Na, R.; Zheng, S.L.; Han, M.; Yu, H.; Jiang, D.; Shah, S.; Ewing, C.M.; Zhang, L.; Novakovic, K.; Petkewicz, J.; Gulukota, K.; Helseth, D.L., Jr; Quinn, M.; Humphries, E.; Wiley, K.E.; Isaacs, S.D.; Wu, Y.; Liu, X.; Zhang, N.; Wang, C.H.; Khandekar, J.; Hulick, P.J.; Shevrin, D.H.; Cooney, K.A.; Shen, Z.; Partin, A.W.; Carter, H.B.; Carducci, M.A.; Eisenberger, M.A.; Denmeade, S.R.; McGuire, M.; Walsh, P.C.; Helfand, B.T.; Brendler, C.B.; Ding, Q.; Xu, J.; Isaacs, W.B. Germline mutations in ATM and BRCA1/2 distinguish risk for lethal and indolent prostate cancer and are associated with early age at death. Eur. Urol., 2017, 71(5), 740-747.
[http://dx.doi.org/10.1016/j.eururo.2016.11.033] [PMID: 27989354]
[26]
Mateo, J.; Porta, N.; Bianchini, D.; McGovern, U.; Elliott, T.; Jones, R.; Syndikus, I.; Ralph, C.; Jain, S.; Varughese, M.; Parikh, O.; Crabb, S.; Robinson, A.; McLaren, D.; Birtle, A.; Tanguay, J.; Miranda, S.; Figueiredo, I.; Seed, G.; Bertan, C.; Flohr, P.; Ebbs, B.; Rescigno, P.; Fowler, G.; Ferreira, A.; Riisnaes, R.; Pereira, R.; Curcean, A.; Chandler, R.; Clarke, M.; Gurel, B.; Crespo, M.; Nava Rodrigues, D.; Sandhu, S.; Espinasse, A.; Chatfield, P.; Tunariu, N.; Yuan, W.; Hall, E.; Carreira, S.; de Bono, J.S. Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): A multicentre, open-label, randomised, phase 2 trial. Lancet Oncol., 2020, 21(1), 162-174.
[http://dx.doi.org/10.1016/S1470-2045(19)30684-9] [PMID: 31806540]
[27]
Mateo, J.; Carreira, S.; Sandhu, S.; Miranda, S.; Mossop, H.; Perez-Lopez, R.; Nava Rodrigues, D.; Robinson, D.; Omlin, A.; Tunariu, N.; Boysen, G.; Porta, N.; Flohr, P.; Gillman, A.; Figueiredo, I.; Paulding, C.; Seed, G.; Jain, S.; Ralph, C.; Protheroe, A.; Hussain, S.; Jones, R.; Elliott, T.; McGovern, U.; Bianchini, D.; Goodall, J.; Zafeiriou, Z.; Williamson, C.T.; Ferraldeschi, R.; Riisnaes, R.; Ebbs, B.; Fowler, G.; Roda, D.; Yuan, W.; Wu, Y.M.; Cao, X.; Brough, R.; Pemberton, H.; A’Hern, R.; Swain, A.; Kunju, L.P.; Eeles, R.; Attard, G.; Lord, C.J.; Ashworth, A.; Rubin, M.A.; Knudsen, K.E.; Feng, F.Y.; Chinnaiyan, A.M.; Hall, E.; de Bono, J.S. DNA-repair defects and olaparib in metastatic prostate cancer. N. Engl. J. Med., 2015, 373(18), 1697-1708.
[http://dx.doi.org/10.1056/NEJMoa1506859] [PMID: 26510020]
[28]
Robson, M.; Im, S-A.; Senkus, E.; Binghe, Xu.; Domchek, S.M.; Masuda, N.; Delaloge, S.; Li, W.; Tung, N.; Armstrong, A.; Runswick, S.; Conte, P.; Flohr, P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N. Engl. J. Med., 2017, 377(17), 1700.
[http://dx.doi.org/10.1056/NEJMx170012] [PMID: 28792849]
[29]
O’Connor, M.J. Targeting the DNA damage response in cancer. Mol. Cell, 2015, 60(4), 547-560.
[http://dx.doi.org/10.1016/j.molcel.2015.10.040] [PMID: 26590714]
[30]
Fong, P.C.; Boss, D.S.; Yap, T.A.; Tutt, A.; Wu, P.; Mergui-Roelvink, M.; Mortimer, P.; Swaisland, H.; Lau, A.; O’Connor, M.J.; Ashworth, A.; Carmichael, J.; Kaye, S.B.; Schellens, J.H.; de Bono, J.S. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N. Engl. J. Med., 2009, 361(2), 123-134.
[http://dx.doi.org/10.1056/NEJMoa0900212] [PMID: 19553641]
[31]
Kaufman, B.; Shapira-Frommer, R.; Schmutzler, R.K.; Audeh, M.W.; Friedlander, M.; Balmaña, J.; Mitchell, G.; Fried, G.; Stemmer, S.M.; Hubert, A.; Rosengarten, O.; Steiner, M.; Loman, N.; Bowen, K.; Fielding, A.; Domchek, S.M. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J. Clin. Oncol., 2015, 33(3), 244-250.
[http://dx.doi.org/10.1200/JCO.2014.56.2728] [PMID: 25366685]
[32]
Nizialek, E.; Antonarakis, E.S. PARP Inhibitors in Metastatic Prostate Cancer: Evidence to Date. Cancer Manag. Res., 2020, 12, 8105-8114.
[http://dx.doi.org/10.2147/CMAR.S227033] [PMID: 32982407]
[33]
de Bono, J.; Mateo, J.; Fizazi, K.; Saad, F.; Shore, N.; Sandhu, S.; Chi, K.N.; Sartor, O.; Agarwal, N.; Olmos, D.; Thiery-Vuillemin, A.; Twardowski, P.; Mehra, N.; Goessl, C.; Kang, J.; Burgents, J.; Wu, W.; Kohlmann, A.; Adelman, C.A.; Hussain, M. Olaparib for metastatic castration-resistant prostate cancer. N. Engl. J. Med., 2020, 382(22), 2091-2102.
[http://dx.doi.org/10.1056/NEJMoa1911440] [PMID: 32343890]
[34]
Hussain, M.; Mateo, J.; Fizazi, K.; Saad, F.; Shore, N.; Sandhu, S.; Chi, K.N.; Sartor, O.; Agarwal, N.; Olmos, D.; Thiery-Vuillemin, A.; Twardowski, P.; Roubaud, G.; Özgüroğlu, M.; Kang, J.; Burgents, J.; Gresty, C.; Corcoran, C.; Adelman, C.A.; de Bono, J. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N. Engl. J. Med., 2020, 383(24), 2345-2357.
[http://dx.doi.org/10.1056/NEJMoa2022485] [PMID: 32955174]
[35]
Goodall, J.; Mateo, J.; Yuan, W.; Mossop, H.; Porta, N.; Miranda, S.; Perez-Lopez, R.; Dolling, D.; Robinson, D.R.; Sandhu, S.; Fowler, G.; Ebbs, B.; Flohr, P.; Seed, G.; Rodrigues, D.N.; Boysen, G.; Bertan, C.; Atkin, M.; Clarke, M.; Crespo, M.; Figueiredo, I.; Riisnaes, R.; Sumanasuriya, S.; Rescigno, P.; Zafeiriou, Z.; Sharp, A.; Tunariu, N.; Bianchini, D.; Gillman, A.; Lord, C.J.; Hall, E.; Chinnaiyan, A.M.; Carreira, S.; de Bono, J.S. Circulating cell-free DNA to guide prostate cancer treatment with PARP inhibition. Cancer Discov., 2017, 7(9), 1006-1017.
[http://dx.doi.org/10.1158/2159-8290.CD-17-0261] [PMID: 28450425]
[36]
Karzai, F.; VanderWeele, D.; Madan, R.A.; Owens, H.; Cordes, L.M.; Hankin, A.; Couvillon, A.; Nichols, E.; Bilusic, M.; Beshiri, M.L.; Kelly, K.; Krishnasamy, V.; Lee, S.; Lee, M.J.; Yuno, A.; Trepel, J.B.; Merino, M.J.; Dittamore, R.; Marté, J.; Donahue, R.N.; Schlom, J.; Killian, K.J.; Meltzer, P.S.; Steinberg, S.M.; Gulley, J.L.; Lee, J.M.; Dahut, W.L. Activity of durvalumab plus olaparib in metastatic castration-resistant prostate cancer in men with and without DNA damage repair mutations. J. Immunother. Cancer, 2018, 6(1), 141.
[http://dx.doi.org/10.1186/s40425-018-0463-2] [PMID: 30514390]
[37]
Clarke, N.; Wiechno, P.; Alekseev, B.; Sala, N.; Jones, R.; Kocak, I.; Chiuri, V.E.; Jassem, J.; Fléchon, A.; Redfern, C.; Goessl, C.; Burgents, J.; Kozarski, R.; Hodgson, D.; Learoyd, M.; Saad, F. Olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: A randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol., 2018, 19(7), 975-986.
[http://dx.doi.org/10.1016/S1470-2045(18)30365-6] [PMID: 29880291]
[38]
Perez-Lopez, R.; Mateo, J.; Mossop, H.; Blackledge, M.D.; Collins, D.J.; Rata, M.; Morgan, V.A.; Macdonald, A.; Sandhu, S.; Lorente, D.; Rescigno, P.; Zafeiriou, Z.; Bianchini, D.; Porta, N.; Hall, E.; Leach, M.O.; de Bono, J.S.; Koh, D.M.; Tunariu, N. Diffusion-weighted Imaging as a Treatment Response Biomarker for Evaluating Bone Metastases in Prostate Cancer: A Pilot Study. Radiology, 2017, 283(1), 168-177.
[http://dx.doi.org/10.1148/radiol.2016160646] [PMID: 27875103]
[39]
FDA FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer. Available from: https://www.fda.gov/drugs/fda-grants-accelerated-approval-rucaparib-brca-mutated-metastatic-castration-resistant-prostate#:~:text=Drugs-,FDA%20grants%20accelerated%20approval%20to%20rucaparib%20for%20BRCA,metastatic%20castration%2Dresistant%20prostate%20cancer&text=On%20May%2015%2C%202020%2C%20the,%2C%20Clovis%20Oncology%2C%20Inc (Accessed January 1, 2021).
[40]
Abida, W.; Patnaik, A.; Campbell, D.; Shapiro, J.; Bryce, A.H.; McDermott, R.; Sautois, B.; Vogelzang, N.J.; Bambury, R.M.; Voog, E.; Zhang, J.; Piulats, J.M.; Ryan, C.J.; Merseburger, A.S.; Daugaard, G.; Heidenreich, A.; Fizazi, K.; Higano, C.S.; Krieger, L.E.; Sternberg, C.N.; Watkins, S.P.; Despain, D.; Simmons, A.D.; Loehr, A.; Dowson, M.; Golsorkhi, T.; Chowdhury, S. Rucaparib in men with metastatic castration-resistant prostate cancer harboring a BRCA1 or BRCA2 gene alteration. J. Clin. Oncol., 2020, 38(32), 3763-3772.
[http://dx.doi.org/10.1200/JCO.20.01035] [PMID: 32795228]
[41]
Abida, W.; Campbell, D.; Patnaik, A.; Shapiro, J. D.; Sautois, B.; Vogelzang, N.J.; Voog, E.G.; Bryce, A.H.; McDermott, R.; Ricci, F.; Rowe, J.; Zhang, J.; Piulats, J.M.; Fizazi, K.; Merseburger, A.S.; Higano, C.S.; Krieger, L.E.; Ryan, C.J.; Feng, F.Y.; Simmons, A.D.; Loehr, A.; Despain, D.; Dowson, M.; Green, F.; Watkins, S.P.; Golsorkhi, T.; Chowdhury, S. Non-BRCA DNA damage repair gene alterations and response to the parp inhibitor rucaparib in metastatic castration-resistant prostate cancer: Analysis from the phase II TRITON2 study. Clin. Cancer Res., 2020, 26(11), 2487-2496.
[42]
Sokolova, A. O.; Yu, E. Y.; Cheng, H. H. Honing in on PARPi response in prostate cancer: from HR pathway to gene-by-gene granularity. Clin. Cancer Res., 2020, 26(11), 2439-2440.
[43]
Fizazi, K.; Shore, N.; Tammela, T.L.; Ulys, A.; Vjaters, E.; Polyakov, S.; Jievaltas, M.; Luz, M.; Alekseev, B.; Kuss, I.; Kappeler, C.; Snapir, A.; Sarapohja, T.; Smith, M.R. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N. Engl. J. Med., 2019, 380(13), 1235-1246.
[http://dx.doi.org/10.1056/NEJMoa1815671] [PMID: 30763142]
[44]
Fizazi, K.; Shore, N.; Tammela, T.L.; Ulys, A.; Vjaters, E.; Polyakov, S.; Jievaltas, M.; Luz, M.; Alekseev, B.; Kuss, I.; Le Berre, M.A.; Petrenciuc, O.; Snapir, A.; Sarapohja, T.; Smith, M.R. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N. Engl. J. Med., 2020, 383(11), 1040-1049.
[http://dx.doi.org/10.1056/NEJMoa2001342] [PMID: 32905676]
[45]
Matsubara, N.; Mukai, H.; Hosono, A.; Onomura, M.; Sasaki, M.; Yajima, Y.; Hashizume, K.; Yasuda, M.; Uemura, M.; Zurth, C. Phase 1 study of darolutamide (ODM-201): A new-generation androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer. Cancer Chemother. Pharmacol., 2017, 80(6), 1063-1072.
[http://dx.doi.org/10.1007/s00280-017-3417-3] [PMID: 28801852]
[46]
Shore, N.; Zurth, C.; Fricke, R.; Gieschen, H.; Graudenz, K.; Koskinen, M.; Ploeger, B.; Moss, J.; Prien, O.; Borghesi, G.; Petrenciuc, O.; Tammela, T.L.; Kuss, I.; Verholen, F.; Smith, M.R.; Fizazi, K. Evaluation of clinically relevant drug-drug interactions and population pharmacokinetics of darolutamide in patients with nonmetastatic castration-resistant prostate cancer: results of pre-specified and post hoc analyses of the phase III ARAMIS trial. Target. Oncol., 2019, 14(5), 527-539.
[http://dx.doi.org/10.1007/s11523-019-00674-0] [PMID: 31571095]
[47]
Zurth, C.; Koskinen, M.; Fricke, R.; Prien, O.; Korjamo, T.; Graudenz, K.; Denner, K.; Bairlein, M.; von Bühler, C.J.; Wilkinson, G.; Gieschen, H. Drug-drug interaction potential of darolutamide: In vitro and clinical studies. Eur. J. Drug Metab. Pharmacokinet., 2019, 44(6), 747-759.
[http://dx.doi.org/10.1007/s13318-019-00577-5] [PMID: 31571146]
[48]
FDA FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-certain-type-prostate-cancer-using-novel- clinical-trial-endpoint (Accessed January 1, 2021).
[49]
FDA FDA approves apalutamide for metastatic castration-sensitive prostate cancer. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-apalutamide-metastatic-castration-sensitive-prostate-cancer (Accessed January 1, 2021).
[50]
Smith, M.R.; Saad, F.; Chowdhury, S.; Oudard, S.; Hadaschik, B.A.; Graff, J.N.; Olmos, D.; Mainwaring, P.N.; Lee, J.Y.; Uemura, H.; Lopez-Gitlitz, A.; Trudel, G.C.; Espina, B.M.; Shu, Y.; Park, Y.C.; Rackoff, W.R.; Yu, M.K.; Small, E.J. Apalutamide treatment and metastasis-free survival in prostate cancer. N. Engl. J. Med., 2018, 378(15), 1408-1418.
[http://dx.doi.org/10.1056/NEJMoa1715546] [PMID: 29420164]
[51]
Small, E.J.; Saad, F.; Chowdhury, S.; Oudard, S.; Hadaschik, B.A.; Graff, J.N.; Olmos, D.; Mainwaring, P.N.; Lee, J.Y.; Uemura, H.; De Porre, P.; Smith, A.A.; Zhang, K.; Lopez-Gitlitz, A.; Smith, M.R. Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer. Ann. Oncol., 2019, 30(11), 1813-1820.
[http://dx.doi.org/10.1093/annonc/mdz397] [PMID: 31560066]
[52]
Smith, M.R.; Antonarakis, E.S.; Ryan, C.J.; Berry, W.R.; Shore, N.D.; Liu, G.; Alumkal, J.J.; Higano, C.S.; Chow Maneval, E.; Bandekar, R.; de Boer, C.J.; Yu, M.K.; Rathkopf, D.E. Phase 2 study of the safety and antitumor activity of apalutamide (ARN-509), a potent androgen receptor antagonist, in the high-risk nonmetastatic castration-resistant prostate cancer cohort. Eur. Urol., 2016, 70(6), 963-970.
[http://dx.doi.org/10.1016/j.eururo.2016.04.023] [PMID: 27160947]
[53]
Chi, K.N.; Agarwal, N.; Bjartell, A.; Chung, B.H.; Pereira de Santana Gomes, A.J.; Given, R.; Juárez Soto, Á.; Merseburger, A.S.; Özgüroğlu, M.; Uemura, H.; Ye, D.; Deprince, K.; Naini, V.; Li, J.; Cheng, S.; Yu, M.K.; Zhang, K.; Larsen, J.S.; McCarthy, S.; Chowdhury, S. Apalutamide for metastatic, castration-sensitive prostate cancer. N. Engl. J. Med., 2019, 381(1), 13-24.
[http://dx.doi.org/10.1056/NEJMoa1903307] [PMID: 31150574]
[54]
Agarwal, N.; McQuarrie, K.; Bjartell, A.; Chowdhury, S.; Pereira de Santana Gomes, A.J.; Chung, B.H.; Özgüroğlu, M.; Juárez Soto, Á.; Merseburger, A.S.; Uemura, H.; Ye, D.; Given, R.; Cella, D.; Basch, E.; Miladinovic, B.; Dearden, L.; Deprince, K.; Naini, V.; Lopez-Gitlitz, A.; Chi, K.N. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol., 2019, 20(11), 1518-1530.
[http://dx.doi.org/10.1016/S1470-2045(19)30620-5] [PMID: 31578173]
[55]
Rathkopf, D.E.; Antonarakis, E.S.; Shore, N.D.; Tutrone, R.F.; Alumkal, J.J.; Ryan, C.J.; Saleh, M.; Hauke, R.J.; Bandekar, R.; Maneval, E.C.; de Boer, C.J.; Yu, M.K.; Scher, H.I. Safety and antitumor activity of apalutamide (ARN-509) in metastatic castration-resistant prostate cancer with and without prior abiraterone acetate and prednisone. Clin. Cancer Res., 2017, 23(14), 3544-3551.
[56]
Tsuchiya, T.; Imanaka, K.; Iwaki, Y.; Oyama, R.; Hashine, K.; Yamaguchi, A.; Uemura, H. An open-label, phase 1 study of androgen receptor antagonist, apalutamide in Japanese patients with metastatic castration-resistant prostate cancer. Int. J. Clin. Oncol., 2019, 24(12), 1596-1604.
[http://dx.doi.org/10.1007/s10147-019-01526-7] [PMID: 31446511]
[57]
FDA FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cance. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abiraterone-acetate-combination-prednisone-high-risk-metastatic-castration-sensitive#:~:text=On%20February%207%2C%202018%2C%20the,sensitive%20prostate%20cancer%20(CSPC) (Accessed January 1, 2021).
[58]
Fizazi, K.; Tran, N.; Fein, L.; Matsubara, N.; Rodriguez-Antolin, A.; Alekseev, B.Y.; Özgüroğlu, M.; Ye, D.; Feyerabend, S.; Protheroe, A.; De Porre, P.; Kheoh, T.; Park, Y.C.; Todd, M.B.; Chi, K.N. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N. Engl. J. Med., 2017, 377(4), 352-360.
[http://dx.doi.org/10.1056/NEJMoa1704174] [PMID: 28578607]
[59]
Fizazi, K.; Tran, N.; Fein, L.; Matsubara, N.; Rodriguez-Antolin, A.; Alekseev, B.Y.; Özgüroğlu, M.; Ye, D.; Feyerabend, S.; Protheroe, A.; Sulur, G.; Luna, Y.; Li, S.; Mundle, S.; Chi, K.N. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): Final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol., 2019, 20(5), 686-700.
[http://dx.doi.org/10.1016/S1470-2045(19)30082-8] [PMID: 30987939]
[60]
Fukasawa, S.; Suzuki, H.; Kawaguchi, K.; Noguchi, H.; Enjo, K.; Tran, N.; Todd, M.; Fizazi, K.; Matsubara, N. Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naïve prostate cancer: A subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, Phase 3 study. Jpn. J. Clin. Oncol., 2018, 48(11), 1012-1021.
[http://dx.doi.org/10.1093/jjco/hyy129] [PMID: 30371895]
[61]
Tsao, C.K.; Sfakianos, J.; Liaw, B.; Gimpel-Tetra, K.; Kemeny, M.; Bulone, L.; Shahin, M.; Oh, W.K.; Galsky, M.D.; Phase, I.I. Phase II trial of abiraterone acetate plus prednisone in black men with metastatic prostate cancer. Oncologist, 2016, 21(12), e1414-e1419.
[http://dx.doi.org/10.1634/theoncologist.2016-0026] [PMID: 27742908]
[62]
James, N.D.; de Bono, J.S.; Spears, M.R.; Clarke, N.W.; Mason, M.D.; Dearnaley, D.P.; Ritchie, A.W.S.; Amos, C.L.; Gilson, C.; Jones, R.J.; Matheson, D.; Millman, R.; Attard, G.; Chowdhury, S.; Cross, W.R.; Gillessen, S.; Parker, C.C.; Russell, J.M.; Berthold, D.R.; Brawley, C.; Adab, F.; Aung, S.; Birtle, A.J.; Bowen, J.; Brock, S.; Chakraborti, P.; Ferguson, C.; Gale, J.; Gray, E.; Hingorani, M.; Hoskin, P.J.; Lester, J.F.; Malik, Z.I.; McKinna, F.; McPhail, N.; Money-Kyrle, J.; O’Sullivan, J.; Parikh, O.; Protheroe, A.; Robinson, A.; Srihari, N.N.; Thomas, C.; Wagstaff, J.; Wylie, J.; Zarkar, A.; Parmar, M.K.B.; Sydes, M.R. Abiraterone for prostate cancer not previously treated with hormone therapy. N. Engl. J. Med., 2017, 377(4), 338-351.
[http://dx.doi.org/10.1056/NEJMoa1702900] [PMID: 28578639]
[63]
Chi, K.N.; Protheroe, A.; Rodríguez-Antolín, A.; Facchini, G.; Suttman, H.; Matsubara, N.; Ye, Z.; Keam, B.; Damião, R.; Li, T.; McQuarrie, K.; Jia, B.; De Porre, P.; Martin, J.; Todd, M.B.; Fizazi, K. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): An international, randomised phase 3 trial. Lancet Oncol., 2018, 19(2), 194-206.
[http://dx.doi.org/10.1016/S1470-2045(17)30911-7] [PMID: 29326030]
[64]
Rathkopf, D.E.; Smith, M.R.; de Bono, J.S.; Logothetis, C.J.; Shore, N.D.; de Souza, P.; Fizazi, K.; Mulders, P.F.; Mainwaring, P.; Hainsworth, J.D.; Beer, T.M.; North, S.; Fradet, Y.; Van Poppel, H.; Carles, J.; Flaig, T.W.; Efstathiou, E.; Yu, E.Y.; Higano, C.S.; Taplin, M.E.; Griffin, T.W.; Todd, M.B.; Yu, M.K.; Park, Y.C.; Kheoh, T.; Small, E.J.; Scher, H.I.; Molina, A.; Ryan, C.J.; Saad, F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur. Urol., 2014, 66(5), 815-825.
[http://dx.doi.org/10.1016/j.eururo.2014.02.056] [PMID: 24647231]
[65]
Fizazi, K.; Scher, H.I.; Molina, A.; Logothetis, C.J.; Chi, K.N.; Jones, R.J.; Staffurth, J.N.; North, S.; Vogelzang, N.J.; Saad, F.; Mainwaring, P.; Harland, S.; Goodman, O.B., Jr; Sternberg, C.N.; Li, J.H.; Kheoh, T.; Haqq, C.M.; de Bono, J.S. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: Final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol., 2012, 13(10), 983-992.
[http://dx.doi.org/10.1016/S1470-2045(12)70379-0] [PMID: 22995653]
[66]
Ryan, C.J.; Smith, M.R.; Fizazi, K.; Saad, F.; Mulders, P.F.; Sternberg, C.N.; Miller, K.; Logothetis, C.J.; Shore, N.D.; Small, E.J.; Carles, J.; Flaig, T.W.; Taplin, M.E.; Higano, C.S.; de Souza, P.; de Bono, J.S.; Griffin, T.W.; De Porre, P.; Yu, M.K.; Park, Y.C.; Li, J.; Kheoh, T.; Naini, V.; Molina, A.; Rathkopf, D.E. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): Final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol., 2015, 16(2), 152-160.
[http://dx.doi.org/10.1016/S1470-2045(14)71205-7] [PMID: 25601341]
[67]
Miller, K.; Carles, J.; Gschwend, J.E.; Van Poppel, H.; Diels, J.; Brookman-May, S.D. The phase 3 COU-AA-302 study of abiraterone acetate plus prednisone in men with chemotherapy-naïve metastatic castration-resistant prostate cancer: Stratified analysis based on pain, prostate-specific antigen, and gleason score. Eur. Urol., 2018, 74(1), 17-23.
[http://dx.doi.org/10.1016/j.eururo.2017.08.035] [PMID: 28939004]
[68]
Stein, C.A.; Levin, R.; Given, R.; Higano, C.S.; Nemeth, P.; Bosch, B.; Chapas-Reed, J.; Dreicer, R. Randomized phase 2 therapeutic equivalence study of abiraterone acetate fine particle formulation vs.. originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer: The STAAR study. Urol. Oncol., 2018, 36(2), 81.e9-81.e16.
[http://dx.doi.org/10.1016/j.urolonc.2017.10.018] [PMID: 29150328]
[69]
Smith, M.R.; Rathkopf, D.E.; Mulders, P.F.; Carles, J.; Van Poppel, H.; Li, J.; Kheoh, T.; Griffin, T.W.; Molina, A.; Ryan, C.J. Efficacy and safety of abiraterone acetate in elderly (75 years or older) chemotherapy naïve patients with metastatic castration resistant Prostate cancer. J. Urol., 2015, 194(5), 1277-1284.
[http://dx.doi.org/10.1016/j.juro.2015.07.004] [PMID: 26151676]
[70]
de Bono, J.S.; Logothetis, C.J.; Molina, A.; Fizazi, K.; North, S.; Chu, L.; Chi, K.N.; Jones, R.J.; Goodman, O.B., Jr; Saad, F.; Staffurth, J.N.; Mainwaring, P.; Harland, S.; Flaig, T.W.; Hutson, T.E.; Cheng, T.; Patterson, H.; Hainsworth, J.D.; Ryan, C.J.; Sternberg, C.N.; Ellard, S.L.; Fléchon, A.; Saleh, M.; Scholz, M.; Efstathiou, E.; Zivi, A.; Bianchini, D.; Loriot, Y.; Chieffo, N.; Kheoh, T.; Haqq, C.M.; Scher, H.I. Abiraterone and increased survival in metastatic prostate cancer. N. Engl. J. Med., 2011, 364(21), 1995-2005.
[http://dx.doi.org/10.1056/NEJMoa1014618] [PMID: 21612468]
[71]
Ryan, C.J.; Smith, M.R.; de Bono, J.S.; Molina, A.; Logothetis, C.J.; de Souza, P.; Fizazi, K.; Mainwaring, P.; Piulats, J.M.; Ng, S.; Carles, J.; Mulders, P.F.; Basch, E.; Small, E.J.; Saad, F.; Schrijvers, D.; Van Poppel, H.; Mukherjee, S.D.; Suttmann, H.; Gerritsen, W.R.; Flaig, T.W.; George, D.J.; Yu, E.Y.; Efstathiou, E.; Pantuck, A.; Winquist, E.; Higano, C.S.; Taplin, M.E.; Park, Y.; Kheoh, T.; Griffin, T.; Scher, H.I.; Rathkopf, D.E. Abiraterone in metastatic prostate cancer without previous chemotherapy. N. Engl. J. Med., 2013, 368(2), 138-148.
[http://dx.doi.org/10.1056/NEJMoa1209096] [PMID: 23228172]
[72]
Attard, G.; Reid, A.H.; Yap, T.A.; Raynaud, F.; Dowsett, M.; Settatree, S.; Barrett, M.; Parker, C.; Martins, V.; Folkerd, E.; Clark, J.; Cooper, C.S.; Kaye, S.B.; Dearnaley, D.; Lee, G.; de Bono, J.S. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J. Clin. Oncol., 2008, 26(28), 4563-4571.
[http://dx.doi.org/10.1200/JCO.2007.15.9749] [PMID: 18645193]
[73]
Attard, G.; Reid, A.H.; A’Hern, R.; Parker, C.; Oommen, N.B.; Folkerd, E.; Messiou, C.; Molife, L.R.; Maier, G.; Thompson, E.; Olmos, D.; Sinha, R.; Lee, G.; Dowsett, M.; Kaye, S.B.; Dearnaley, D.; Kheoh, T.; Molina, A.; de Bono, J.S. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J. Clin. Oncol., 2009, 27(23), 3742-3748.
[http://dx.doi.org/10.1200/JCO.2008.20.0642] [PMID: 19470933]
[74]
Tannock, I.; Gospodarowicz, M.; Meakin, W.; Panzarella, T.; Stewart, L.; Rider, W. Treatment of metastatic prostatic cancer with low-dose prednisone: Evaluation of pain and quality of life as pragmatic indices of response. J. Clin. Oncol., 1989, 7(5), 590-597.
[http://dx.doi.org/10.1200/JCO.1989.7.5.590] [PMID: 2709088]
[75]
Arora, V.K.; Schenkein, E.; Murali, R.; Subudhi, S.K.; Wongvipat, J.; Balbas, M.D.; Shah, N.; Cai, L.; Efstathiou, E.; Logothetis, C.; Zheng, D.; Sawyers, C.L. Glucocorticoid receptor confers resistance to antiandrogens by bypassing androgen receptor blockade. Cell, 2013, 155(6), 1309-1322.
[http://dx.doi.org/10.1016/j.cell.2013.11.012] [PMID: 24315100]
[76]
Richards, J.; Lim, A.C.; Hay, C.W.; Taylor, A.E.; Wingate, A.; Nowakowska, K.; Pezaro, C.; Carreira, S.; Goodall, J.; Arlt, W.; McEwan, I.J.; de Bono, J.S.; Attard, G. Interactions of abiraterone, eplerenone, and prednisolone with wild-type and mutant androgen receptor: A rationale for increasing abiraterone exposure or combining with MDV3100. Cancer Res., 2012, 72(9), 2176-2182.
[http://dx.doi.org/10.1158/0008-5472.CAN-11-3980] [PMID: 22411952]
[77]
McKay, R.R.; Werner, L.; Jacobus, S.J.; Jones, A.; Mostaghel, E.A.; Marck, B.T.; Choudhury, A.D.; Pomerantz, M.M.; Sweeney, C.J.; Slovin, S.F.; Morris, M.J.; Kantoff, P.W.; Taplin, M.E. A phase 2 trial of abiraterone acetate without glucocorticoids for men with metastatic castration-resistant prostate cancer. Cancer, 2019, 125(4), 524-532.
[http://dx.doi.org/10.1002/cncr.31836] [PMID: 30427533]
[78]
Cindolo, L.; Natoli, C.; De Nunzio, C.; De Tursi, M.; Valeriani, M.; Giacinti, S.; Micali, S.; Rizzo, M.; Bianchi, G.; Martorana, E.; Scarcia, M.; Ludovico, G.M.; Bove, P.; Laudisi, A.; Selvaggio, O.; Carrieri, G.; Bada, M.; Castellan, P.; Topazio, L.; Boccasile, S.; Ditonno, P.; Chiodini, P.; Schips, L. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer in chemotherapy-naive patients: An italian analysis of patients’ satisfaction. Clin. Genitourin. Cancer, 2017, 15(5), 520-525.
[http://dx.doi.org/10.1016/j.clgc.2017.04.003] [PMID: 28478884]
[79]
Yildirim, B. A.; Onal, C.; Kose, F.; Oymak, E.; Sedef, A. M.; Besen, A. A.; Aksoy, S.; Guler, O. C.; Sumbul, A. T.; Muallaoglu, S.; Mertsoylu, H.; Ozyigit, G. Outcome of loco-regional radiotherapy in metastatic castration-resistant prostate cancer patients treated with abiraterone acetate. Strahlenther. Onkol., 2019, 195(10), 872-881.
[80]
Cindolo, L.; Natoli, C.; De Nunzio, C.; De Tursi, M.; Valeriani, M.; Giacinti, S.; Micali, S.; Rizzo, M.; Bianchi, G.; Martorana, E.; Scarcia, M.; Ludovico, G.M.; Bove, P.; Laudisi, A.; Selvaggio, O.; Carrieri, G.; Bada, M.; Castellan, P.; Boccasile, S.; Ditonno, P.; Chiodini, P.; Verze, P.; Mirone, V.; Schips, L. Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study. BMC Cancer, 2017, 17(1), 753.
[http://dx.doi.org/10.1186/s12885-017-3755-x] [PMID: 29126389]
[81]
Szmulewitz, R.Z.; Peer, C.J.; Ibraheem, A.; Martinez, E.; Kozloff, M.F.; Carthon, B.; Harvey, R.D.; Fishkin, P.; Yong, W.P.; Chiong, E.; Nabhan, C.; Karrison, T.; Figg, W.D.; Stadler, W.M.; Ratain, M.J. Prospective international randomized phase ii study of low-dose abiraterone with food versus standard dose abiraterone in castration-resistant prostate cancer. J. Clin. Oncol., 2018, 36(14), 1389-1395.
[http://dx.doi.org/10.1200/JCO.2017.76.4381] [PMID: 29590007]
[82]
Taplin, M.E.; Montgomery, B.; Logothetis, C.J.; Bubley, G.J.; Richie, J.P.; Dalkin, B.L.; Sanda, M.G.; Davis, J.W.; Loda, M.; True, L.D.; Troncoso, P.; Ye, H.; Lis, R.T.; Marck, B.T.; Matsumoto, A.M.; Balk, S.P.; Mostaghel, E.A.; Penning, T.M.; Nelson, P.S.; Xie, W.; Jiang, Z.; Haqq, C.M.; Tamae, D.; Tran, N.; Peng, W.; Kheoh, T.; Molina, A.; Kantoff, P.W. Intense androgen-deprivation therapy with abiraterone acetate plus leuprolide acetate in patients with localized high-risk prostate cancer: Results of a randomized phase II neoadjuvant study. J. Clin. Oncol., 2014, 32(33), 3705-3715.
[http://dx.doi.org/10.1200/JCO.2013.53.4578] [PMID: 25311217]
[83]
Friedlander, T.W.; Graff, J.N.; Zejnullahu, K.; Anantharaman, A.; Zhang, L.; Paz, R.; Premasekharan, G.; Russell, C.; Huang, Y.; Kim, W.; Aggarwal, R.R.; Lin, A.M.; Fong, L.; Alumkal, J.J.; Beer, T.M.; Sharifi, N.; Alyamani, M.; Dittamore, R.; Small, E.J.; Paris, P.L.; Ryan, C.J. High-dose abiraterone acetate in men with castration resistant prostate cancer. Clin. Genitourin. Cancer, 2017, 15(6), 733-741.e1.
[http://dx.doi.org/10.1016/j.clgc.2017.05.026] [PMID: 28655452]
[84]
Tagawa, S.T.; Posadas, E.M.; Bruce, J.; Lim, E.A.; Petrylak, D.P.; Peng, W.; Kheoh, T.; Maul, S.; Smit, J.W.; Gonzalez, M.D.; De Porre, P.; Tran, N.; Nanus, D.M. Phase 1b study of abiraterone acetate plus prednisone and docetaxel in patients with metastatic castration-resistant prostate cancer. Eur. Urol., 2016, 70(5), 718-721.
[http://dx.doi.org/10.1016/j.eururo.2016.01.028] [PMID: 26852075]
[85]
Kwak, C.; Wu, T.T.; Lee, H.M.; Wu, H.C.; Hong, S.J.; Ou, Y.C.; Byun, S.S.; Rhim, H.Y.; Kheoh, T.; Wan, Y.; Yeh, H.; Yu, M.K.; Kim, C.S. Abiraterone acetate and prednisolone for metastatic castration-resistant prostate cancer failing androgen deprivation and docetaxel-based chemotherapy: A phase II bridging study in Korean and Taiwanese patients. Int. J. Urol., 2014, 21(12), 1239-1244.
[86]
Sun, Y.; Zou, Q.; Sun, Z.; Li, C.; Du, C.; Chen, Z.; Shan, Y.; Huang, Y.; Jin, J.; Ye, Z. Q.; Xie, L.; Lin, G.; Feng, Y.; De Porre, P.; Liu, W.; Ye, D. Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study. Int. J. Urol., 2016, 23(5), 404-411.
[87]
Reid, A.H.; Attard, G.; Danila, D.C.; Oommen, N.B.; Olmos, D.; Fong, P.C.; Molife, L.R.; Hunt, J.; Messiou, C.; Parker, C.; Dearnaley, D.; Swennenhuis, J.F.; Terstappen, L.W.; Lee, G.; Kheoh, T.; Molina, A.; Ryan, C.J.; Small, E.; Scher, H.I.; de Bono, J.S. Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J. Clin. Oncol., 2010, 28(9), 1489-1495.
[http://dx.doi.org/10.1200/JCO.2009.24.6819] [PMID: 20159823]
[88]
Danila, D.C.; Morris, M.J.; de Bono, J.S.; Ryan, C.J.; Denmeade, S.R.; Smith, M.R.; Taplin, M.E.; Bubley, G.J.; Kheoh, T.; Haqq, C.; Molina, A.; Anand, A.; Koscuiszka, M.; Larson, S.M.; Schwartz, L.H.; Fleisher, M.; Scher, H.I. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J. Clin. Oncol., 2010, 28(9), 1496-1501.
[http://dx.doi.org/10.1200/JCO.2009.25.9259] [PMID: 20159814]
[89]
FDA FDA approves enzalutamide for metastatic castration-sensitive prostate cancer. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-metastatic-castration-sensitive-prostate-cancer#:~:text=On%20December%2016%2C%202019%2C%20the,with%20castration%2Dresistant%20prostate%20cancer (Accessed on January 1, 2021).
[90]
Armstrong, A.J.; Szmulewitz, R.Z.; Petrylak, D.P.; Holzbeierlein, J.; Villers, A.; Azad, A.; Alcaraz, A.; Alekseev, B.; Iguchi, T.; Shore, N.D.; Rosbrook, B.; Sugg, J.; Baron, B.; Chen, L.; Stenzl, A. ARCHES: A randomized, phase iii study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J. Clin. Oncol., 2019, 37(32), 2974-2986.
[http://dx.doi.org/10.1200/JCO.19.00799] [PMID: 31329516]
[91]
Penson, D.F.; Armstrong, A.J.; Concepcion, R.; Agarwal, N.; Olsson, C.; Karsh, L.; Dunshee, C.; Wang, F.; Wu, K.; Krivoshik, A.; Phung, D.; Higano, C.S. Enzalutamide versus bicalutamide in castration-resistant prostate cancer: The STRIVE trial. J. Clin. Oncol., 2016, 34(18), 2098-2106.
[http://dx.doi.org/10.1200/JCO.2015.64.9285] [PMID: 26811535]
[92]
Shore, N.D.; Chowdhury, S.; Villers, A.; Klotz, L.; Siemens, D.R.; Phung, D.; van Os, S.; Hasabou, N.; Wang, F.; Bhattacharya, S.; Heidenreich, A. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): A randomised, double-blind, phase 2 study. Lancet Oncol., 2016, 17(2), 153-163.
[http://dx.doi.org/10.1016/S1470-2045(15)00518-5] [PMID: 26774508]
[93]
Iguchi, T.; Tamada, S.; Kato, M.; Yasuda, S.; Machida, Y.; Ohmachi, T.; Ishii, K.; Iwata, H.; Yamamoto, S.; Kanamaru, T.; Morimoto, K.; Hase, T.; Tashiro, K.; Harimoto, K.; Deguchi, T.; Adachi, T.; Iwamoto, K.; Takegaki, Y.; Nakatani, T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: The OCUU-CRPC study. Int. J. Clin. Oncol., 2020, 25(3), 486-494.
[http://dx.doi.org/10.1007/s10147-019-01554-3] [PMID: 31564004]
[94]
Beer, T.M.; Armstrong, A.J.; Rathkopf, D.E.; Loriot, Y.; Sternberg, C.N.; Higano, C.S.; Iversen, P.; Bhattacharya, S.; Carles, J.; Chowdhury, S.; Davis, I.D.; de Bono, J.S.; Evans, C.P.; Fizazi, K.; Joshua, A.M.; Kim, C.S.; Kimura, G.; Mainwaring, P.; Mansbach, H.; Miller, K.; Noonberg, S.B.; Perabo, F.; Phung, D.; Saad, F.; Scher, H.I.; Taplin, M.E.; Venner, P.M.; Tombal, B. Enzalutamide in metastatic prostate cancer before chemotherapy. N. Engl. J. Med., 2014, 371(5), 424-433.
[http://dx.doi.org/10.1056/NEJMoa1405095] [PMID: 24881730]
[95]
Loriot, Y.; Miller, K.; Sternberg, C.N.; Fizazi, K.; De Bono, J.S.; Chowdhury, S.; Higano, C.S.; Noonberg, S.; Holmstrom, S.; Mansbach, H.; Perabo, F.G.; Phung, D.; Ivanescu, C.; Skaltsa, K.; Beer, T.M.; Tombal, B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): Results from a randomised, phase 3 trial. Lancet Oncol., 2015, 16(5), 509-521.
[http://dx.doi.org/10.1016/S1470-2045(15)70113-0] [PMID: 25888263]
[96]
Evans, C.P.; Higano, C.S.; Keane, T.; Andriole, G.; Saad, F.; Iversen, P.; Miller, K.; Kim, C.S.; Kimura, G.; Armstrong, A.J.; Sternberg, C.N.; Loriot, Y.; de Bono, J.; Noonberg, S.B.; Mansbach, H.; Bhattacharya, S.; Perabo, F.; Beer, T.M.; Tombal, B. The prevail study: Primary outcomes by site and extent of baseline disease for enzalutamide-treated men with chemotherapy- naïve metastatic castration-resistant prostate cancer. Eur. Urol., 2016, 70(4), 675-683.
[http://dx.doi.org/10.1016/j.eururo.2016.03.017] [PMID: 27006332]
[97]
Armstrong, A.J.; Lin, P.; Higano, C.S.; Iversen, P.; Sternberg, C.N.; Tombal, B.; Phung, D.; Parli, T.; Krivoshik, A.; Beer, T.M. Prognostic association of prostate-specific antigen decline with clinical outcomes in men with metastatic castration-resistant prostate cancer treated with enzalutamide in a randomized clinical trial. Eur. Urol. Oncol., 2019, 2(6), 677-684.
[98]
Davis, I.D.; Martin, A.J.; Stockler, M.R.; Begbie, S.; Chi, K.N.; Chowdhury, S.; Coskinas, X.; Frydenberg, M.; Hague, W.E.; Horvath, L.G.; Joshua, A.M.; Lawrence, N.J.; Marx, G.; McCaffrey, J.; McDermott, R.; McJannett, M.; North, S.A.; Parnis, F.; Parulekar, W.; Pook, D.W.; Reaume, M.N.; Sandhu, S.K.; Tan, A.; Tan, T.H.; Thomson, A.; Tu, E.; Vera-Badillo, F.; Williams, S.G.; Yip, S.; Zhang, A.Y.; Zielinski, R.R.; Sweeney, C.J. Enzalutamide with standard first-line therapy in metastatic prostate cancer. N. Engl. J. Med., 2019, 381(2), 121-131.
[http://dx.doi.org/10.1056/NEJMoa1903835] [PMID: 31157964]
[99]
Scher, H.I.; Fizazi, K.; Saad, F.; Taplin, M.E.; Sternberg, C.N.; Miller, K.; de Wit, R.; Mulders, P.; Chi, K.N.; Shore, N.D.; Armstrong, A.J.; Flaig, T.W.; Fléchon, A.; Mainwaring, P.; Fleming, M.; Hainsworth, J.D.; Hirmand, M.; Selby, B.; Seely, L.; de Bono, J.S. Increased survival with enzalutamide in prostate cancer after chemotherapy. N. Engl. J. Med., 2012, 367(13), 1187-1197.
[http://dx.doi.org/10.1056/NEJMoa1207506] [PMID: 22894553]
[100]
Loriot, Y.; Fizazi, K.; de Bono, J.S.; Forer, D.; Hirmand, M.; Scher, H.I. Enzalutamide in castration-resistant prostate cancer patients with visceral disease in the liver and/or lung: Outcomes from the randomized controlled phase 3 AFFIRM trial. Cancer, 2017, 123(2), 253-262.
[http://dx.doi.org/10.1002/cncr.30336] [PMID: 27648814]
[101]
Graff, J.N.; Alumkal, J.J.; Drake, C.G.; Thomas, G.V.; Redmond, W.L.; Farhad, M.; Cetnar, J.P.; Ey, F.S.; Bergan, R.C.; Slottke, R.; Beer, T.M. Early evidence of anti-PD-1 activity in enzalutamide-resistant prostate cancer. Oncotarget, 2016, 7(33), 52810-52817.
[http://dx.doi.org/10.18632/oncotarget.10547] [PMID: 27429197]
[102]
Gibbons, J.A.; Ouatas, T.; Krauwinkel, W.; Ohtsu, Y.; van der Walt, J.S.; Beddo, V.; de Vries, M.; Mordenti, J. Clinical pharmacokinetic studies of enzalutamide. Clin. Pharmacokinet., 2015, 54(10), 1043-1055.
[http://dx.doi.org/10.1007/s40262-015-0271-5] [PMID: 25917876]
[103]
Liu, Y.M.; Wu, P.; Fukushi, R.; Yamada, S.; Chen, Q. Pharmacokinetics and safety of enzalutamide in healthy chinese male volunteers. Clin. Ther., 2019, 41(2), 261-268.
[http://dx.doi.org/10.1016/j.clinthera.2018.12.002] [PMID: 30642613]
[104]
Gibbons, J.A.; de Vries, M.; Krauwinkel, W.; Ohtsu, Y.; Noukens, J.; van der Walt, J.S.; Mol, R.; Mordenti, J.; Ouatas, T. Pharmacokinetic drug interaction studies with enzalutamide. Clin. Pharmacokinet., 2015, 54(10), 1057-1069.
[http://dx.doi.org/10.1007/s40262-015-0283-1] [PMID: 25929560]
[105]
de Bono, J.S.; Chowdhury, S.; Feyerabend, S.; Elliott, T.; Grande, E.; Melhem-Bertrandt, A.; Baron, B.; Hirmand, M.; Werbrouck, P.; Fizazi, K. Antitumour activity and safety of enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with abiraterone acetate plus prednisone for ≥24 weeks in europe. Eur. Urol., 2018, 74(1), 37-45.
[http://dx.doi.org/10.1016/j.eururo.2017.07.035] [PMID: 28844372]
[106]
Attard, G.; Borre, M.; Gurney, H.; Loriot, Y.; Andresen-Daniil, C.; Kalleda, R.; Pham, T.; Taplin, M.E. Abiraterone alone or in combination with enzalutamide in metastatic castration-resistant prostate cancer with rising prostate-specific antigen during enzalutamide treatment. J. Clin. Oncol., 2018, 36(25), 2639-2646.
[http://dx.doi.org/10.1200/JCO.2018.77.9827] [PMID: 30028657]
[107]
Shore, N.D.; Saltzstein, D.; Sieber, P.; Mehlhaff, B.; Gervasi, L.; Phillips, J.; Wong, Y.N.; Pei, H.; McGowan, T. Results of a real- world study of enzalutamide and abiraterone acetate with prednisone tolerability (REAAcT). Clin. Genitourin. Cancer, 2019, 17(6), 457-463.e6.
[http://dx.doi.org/10.1016/j.clgc.2019.07.017] [PMID: 31473120]
[108]
Krauwinkel, W.; Noukens, J.; van Dijk, J.; Popa, S.; Ouatas, T.; de Vries, M.; Phung, D.; Gibbons, J.; Mordenti, J.; Mateva, L. A comparison of the pharmacokinetics and safety of enzalutamide in subjects with hepatic impairment and matched healthy subjects. J. Clin. Pharm. Ther., 2017, 42(3), 268-275.
[http://dx.doi.org/10.1111/jcpt.12503] [PMID: 28251667]
[109]
Abbaspour Babaei, M.; Kamalidehghan, B.; Saleem, M.; Huri, H.Z.; Ahmadipour, F. Receptor tyrosine kinase (c-Kit) inhibitors: A potential therapeutic target in cancer cells. Drug Des. Devel. Ther., 2016, 10, 2443-2459.
[http://dx.doi.org/10.2147/DDDT.S89114] [PMID: 27536065]
[110]
Swami, U.; McFarland, T.R.; Nussenzveig, R.; Agarwal, N. Advanced prostate cancer: Treatment advances and future directions. Trends Cancer, 2020, 6(8), 702-715.
[http://dx.doi.org/10.1016/j.trecan.2020.04.010] [PMID: 32534790]

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