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REVIEW

Treatment Landscape for Patients with Castration-Resistant Prostate Cancer: Patient Selection and Unmet Clinical Needs

, , , ORCID Icon & ORCID Icon
Pages 339-350 | Received 10 Jul 2022, Accepted 14 Sep 2022, Published online: 29 Sep 2022

References

  • Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660
  • Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res. 1941;1:293–297.
  • Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2015;373(8):737–746. doi:10.1056/NEJMoa1503747
  • James ND, Sydes MR, Clarke NW, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016;387(10024):1163–1177. doi:10.1016/S0140-6736(15)01037-5
  • Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med. 2017;377(4):352–360. doi:10.1056/NEJMoa1704174
  • James ND, de Bono JS, Spears MR, et al. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med. 2017;377(4):338–351. doi:10.1056/NEJMoa1702900
  • Armstrong AJ, Azad AA, Iguchi T, et al. Improved survival with enzalutamide in patients with metastatic hormone-sensitive prostate cancer. Am J Clin Oncol. 2022;40(15):1616–1622. doi:10.1200/JCO.22.00193
  • Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381(1):13–24. doi:10.1056/NEJMoa1903307
  • Francini E, Gray KP, Xie W, et al. Time of metastatic disease presentation and volume of disease are prognostic for metastatic hormone sensitive prostate cancer (mHSPC). Prostate. 2018;78(12):889–895. doi:10.1002/pros.23645
  • Hussain M, Fizazi K, Saad F, et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2018;378(26):2465–2474. doi:10.1056/NEJMoa1800536
  • Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408–1418. doi:10.1056/NEJMoa1715546
  • Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235–1246. doi:10.1056/NEJMoa1815671
  • Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351(15):1502–1512. doi:10.1056/NEJMoa040720
  • de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376(9747):1147–1154. doi:10.1016/S0140-6736(10)61389-X
  • de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364(21):1995–2005. doi:10.1056/NEJMoa1014618
  • Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187–1197. doi:10.1056/NEJMoa1207506
  • Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213–223. doi:10.1056/NEJMoa1213755
  • Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385(12):1091–1103. doi:10.1056/NEJMoa2107322
  • Hussain M, Mateo J, Fizazi K, et al. Survival with olaparib in metastatic castration-resistant prostate cancer. N Engl J Med. 2020;383(24):2345–2357. doi:10.1056/NEJMoa2022485
  • Abida W, Patnaik A, Campbell D, et al. Rucaparib in men with metastatic castration-resistant prostate cancer harboring a BRCA1 or BRCA2 Gene alteration. Am J Clin Oncol. 2020;38(32):3763–3772. doi:10.1200/JCO.20.01035
  • Karantanos T, Corn PG, Thompson TC. Prostate cancer progression after androgen deprivation therapy: mechanisms of castrate resistance and novel therapeutic approaches. Oncogene. 2013;32(49):5501–5511. doi:10.1038/onc.2013.206
  • Xie W, Regan MM, Buyse M, et al. Metastasis-free survival is a strong surrogate of overall survival in localized prostate cancer. Am J Clin Oncol. 2017;35(27):3097–3104. doi:10.1200/JCO.2017.73.9987
  • Smith MR, Cook R, Lee KA, et al. Disease and host characteristics as predictors of time to first bone metastasis and death in men with progressive castration-resistant nonmetastatic prostate cancer. Cancer. 2011;117(10):2077–2085. doi:10.1002/cncr.25762
  • Smith MR, Saad F, Oudard S, et al. Denosumab and bone metastasis-free survival in men with nonmetastatic castration-resistant prostate cancer: exploratory analyses by baseline prostate-specific antigen doubling time. Am J Clin Oncol. 2013;31(30):3800–3806. doi:10.1200/JCO.2012.44.6716
  • Sternberg CN, Fizazi K, Saad F, et al. Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2020;382(23):2197–2206. doi:10.1056/NEJMoa2003892
  • Smith MR, Saad F, Chowdhury S, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79(1):150–158. doi:10.1016/j.eururo.2020.08.011
  • Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med. 2020;383(11):1040–1049. doi:10.1056/NEJMoa2001342
  • Mottet N, Cornford P, van den Bergh RCN, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG guidelines on prostate cancer update. Eur Urol. 2022;79:243–262.
  • Schaeffer E, Srinivas S, Antonarakis ES, et al. NCCN guidelines insights: prostate cancer, version 1.2021. J Natl Compr Cancer Netw. 2021;19(2):134–143. doi:10.6004/jnccn.2021.0008
  • Kumar J, Jazayeri SB, Gautam S, et al. Comparative efficacy of apalutamide darolutamide and enzalutamide for treatment of non-metastatic castrate-resistant prostate cancer: a systematic review and network meta-analysis. Urol Oncol. 2020;38(11):826–834. doi:10.1016/j.urolonc.2020.03.022
  • Mori K, Mostafaei H, Pradere B, et al. Apalutamide, enzalutamide, and darolutamide for non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis. Int J Clin Oncol. 2020;25(11):1892–1900. doi:10.1007/s10147-020-01777-9
  • Hird AE, Magee DE, Bhindi B, et al. A systematic review and network meta-analysis of novel androgen receptor inhibitors in non-metastatic castration-resistant prostate cancer. Clin Genitourin Cancer. 2020;18(5):343–350. doi:10.1016/j.clgc.2020.02.005
  • Wenzel M, Nocera L, Collà Ruvolo C, et al. Overall survival and adverse events after treatment with darolutamide vs. apalutamide vs. enzalutamide for high-risk non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis. Prostate Cancer Prostatic Dis. 2021;25:139–148. doi:10.1038/s41391-021-00395-4
  • Moilanen AM, Riikonen R, Oksala R, et al. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. 2015;5:12007. doi:10.1038/srep12007
  • Fizazi K, Massard C, Bono P, et al. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label Phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014;15(9):975–985. doi:10.1016/S1470-2045(14)70240-2
  • Del Re M, Fogli S, Derosa L, et al. The role of drug-drug interactions in prostate cancer treatment: focus on Abiraterone acetate/prednisone and enzalutamide. Cancer Treat Rev. 2017;55:71–82. doi:10.1016/j.ctrv.2017.03.001
  • Duran I, Carles J, Bulat I, et al. Pharmacokinetic drug-drug interaction of apalutamide, part 1: clinical studies in healthy men and patients with castration-resistant prostate cancer. Clin Pharmacokinet. 2020;59(9):1135–1148. doi:10.1007/s40262-020-00882-2
  • Shore N, Zurth C, Fricke R, et al. 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. doi:10.1007/s11523-019-00674-0
  • Fendler WP, Weber M, Iravani A, et al. Prostate-specific membrane antigen ligand positron emission tomography in men with nonmetastatic castration-resistant prostate cancer. Clin Cancer Res. 2019;25(24):7448–7454. doi:10.1158/1078-0432.CCR-19-1050
  • Noonan KL, North S, Bitting RL, et al. Clinical activity of Abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after enzalutamide. Ann Oncol. 2013;24(7):1802–1807. doi:10.1093/annonc/mdt138
  • Antonarakis ES, Lu C, Wang H, et al. AR-V7 and resistance to enzalutamide and Abiraterone in prostate cancer. N Engl J Med. 2014;371(11):1028–1038. doi:10.1056/NEJMoa1315815
  • Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351(15):1513–1520. doi:10.1056/NEJMoa041318
  • Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368(2):138–148. doi:10.1056/NEJMoa1209096
  • Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371(5):424–433. doi:10.1056/NEJMoa1405095
  • Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363(5):411–422. doi:10.1056/NEJMoa1001294
  • Antonarakis ES, Piulats JM, Gross-Goupil M, et al. Pembrolizumab for treatment-refractory metastatic castration-resistant prostate cancer: multicohort, open-label Phase II KEYNOTE-199 study. Am J Clin Oncol. 2020;38(5):395–405. doi:10.1200/JCO.19.01638
  • Golshayan AR, Antonarakis ES. Enzalutamide: an evidence-based review of its use in the treatment of prostate cancer. Core Evid. 2013;8:27–35. doi:10.2147/CE.S34747
  • Cone EB, Reese S, Marchese M, et al. Cardiovascular toxicities associated with Abiraterone compared to enzalutamide-A pharmacovigilance study. EClinicalMedicine. 2021;36:100887. doi:10.1016/j.eclinm.2021.100887
  • Oudard S, Fizazi K, Sengeløv L, et al. Cabazitaxel versus docetaxel as first-line therapy for patients with metastatic castration-resistant prostate cancer: a randomized phase III Trial-FIRSTANA. Am J Clin Oncol. 2017;35(28):3189–3197. doi:10.1200/JCO.2016.72.1068
  • de Wit R, de Bono J, Sternberg CN, et al. Cabazitaxel versus abiraterone or enzalutamide in metastatic prostate cancer. N Engl J Med. 2019;381(26):2506–2518. doi:10.1056/NEJMoa1911206
  • EMA. EMA restricts use of prostate cancer medicine XOFIGO. Available from: https://www.ema.europa.eu/en/news/ema-restricts-use-prostate-cancer-medicine-xofigo. Accessed September 14, 2022.
  • Smith M, Parker C, Saad F, et al. Addition of radium-223 to Abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(3):408–419. doi:10.1016/S1470-2045(18)30860-X
  • Davis ID, Martin AJ, Stockler MR, et al. Enzalutamide with standard first-line therapy in metastatic prostate cancer. N Engl J Med. 2019;381(2):121–131. doi:10.1056/NEJMoa1903835
  • Agarwal N, Chowdhury S, Bjartell A, et al. Time to second progression (PFS2) in patients (pts) from TITAN with metastatic castration-sensitive prostate cancer (mCSPC) by first subsequent therapy (hormonal vs. taxane). J Clin Oncol. 2020;38:82. doi:10.1200/JCO.2020.38.6_suppl.82
  • Smith MR, Hussain M, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. 2022;386(12):1132–1142. doi:10.1056/NEJMoa2119115
  • Fizazi K, Foulon S, Carles J, et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design. Lancet. 2022;399(10336):1695–1707. doi:10.1016/S0140-6736(22)00367-1
  • Chi NK, Rathkopf DE, Smith MR, et al. Phase 3 MAGNITUDE study: first results of niraparib (NIRA) with Abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. J Clin Oncol. 2022;40:12. doi:10.1200/JCO.21.01891
  • Saad FA, Armstrong AJ, Thiery-Vuillemin A, et al. PROpel: phase III trial of olaparib (ola) and Abiraterone (abi) versus placebo (pbo) and abi as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2022;40:11. doi:10.1200/JCO.2022.40.6_suppl.011
  • Hofman MS, Emmett L, Sandhu S, et al. [177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. Lancet. 2021;397(10276):797–804. doi:10.1016/S0140-6736(21)00237-3
  • Hofman MS, Emmett L, Sandhu S, et al. TheraP: 177 Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel—Overall survival after median follow-up of 3 years (ANZUP 1603). J Clin Oncol. 2022;40:5000. doi:10.1200/JCO.2022.40.16_suppl.5000
  • Kuo P, Hsu H-C, Lin T-M, et al. H1-antihistamines reduce the risk of hepatocellular carcinoma in patients with hepatitis B virus, hepatitis C virus, or dual hepatitis B virus-hepatitis C virus infection. J Clin Oncol. 2022;40:1206–1219. doi:10.1200/JCO.21.01802
  • Attard G, Murphy L, Clarke NW, et al. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022;399(10323):447–460. doi:10.1016/S0140-6736(21)02437-5