Treatment Landscape for Metastatic Castrate-Sensitive Prostate Cancer: A Review

References

• Denmeade SR, Isaacs JT. A history of prostate cancer treatment. Nat Rev Cancer. 2002;2(5):389–396. PMID: 12044015; PMCID: PMC4124639. doi:10.1038/nrc801
   PubMed Web of Science ®Google Scholar
• Veurink M, Koster M, Berg LT. The history of DES, lessons to be learned. Pharm World Sci. 2005;27(3):139–143. doi:10.1007/s11096-005-3663-z
   PubMedGoogle Scholar
• Labrie F, Dupont A, Belanger A, et al. New hormonal therapy in prostatic carcinoma: combined treatment with an LHRH agonist and an antiandrogen. Clin Invest Med. 1982;5(4):267–275. PMID: 6819101.
   PubMed Web of Science ®Google Scholar
• Conn PM, Rogers DC, Seay SG. Biphasic regulation of the gonadotropin-releasing hormone receptor by receptor microaggregation and intracellular Ca2+ levels. Mol Pharmacol. 1984;25(1):51–55.
   PubMed Web of Science ®Google Scholar
• Crawford ED, Hou AH. The role of LHRH antagonists in the treatment of prostate cancer. Oncology. 2009;23(7):626–630. PMID: 19626830.
   PubMed Web of Science ®Google Scholar
• Clinton TN, Woldu SL, Raj GV. Degarelix versus luteinizing hormone-releasing hormone agonists for the treatment of prostate cancer. Expert Opin Pharmacother. 2017;18(8):825–832. PMID: 28480768; PMCID: PMC7171911. doi:10.1080/14656566.2017.1328056
   PubMed Web of Science ®Google Scholar
• Eisenbergerg M, Blymenstein B, Crawford E, et al. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998;339:1036–1042. doi:10.1056/NEJM199810083391504
   PubMed Web of Science ®Google Scholar
• Beer T, Armstrong A, Rathkopf D, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371:424–433. doi:10.1056/NEJMoa1405095
   PubMed Web of Science ®Google Scholar
• Gravis G, Fizazi K, Joly F, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, Phase 3 trial. Lancet Oncol. 2013;14(2):149–158. doi:10.1016/S1470-2045(12)70560-0
   PubMed Web of Science ®Google Scholar
• Sweeney C, Chen Y-H, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2015;373:737–746. doi:10.1056/NEJMoa1503747
   PubMed Web of Science ®Google Scholar
• James ND, Sydes MR, Clarke NW. 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 randomized controlled trial. Lancet. 2016;387(10024):1163–1177. doi:10.1016/S0140-6736(15)01037-5
   PubMed Web of Science ®Google Scholar
• Clarke NW, Ali A, Ingleby FC, et al. Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial. Anna Oncol. 2019;30(12):1992–2003. doi:10.1093/annonc/mdz396
   PubMed Web of Science ®Google Scholar
• Fizazi K, Tran N, Fein L. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med. 2017;377:352–360. doi:10.1056/NEJMoa1704174
   PubMed Web of Science ®Google Scholar
• Davis ID, Martin AJ, Stockler MR. Enzalutamide with standard first-line therapy in metastatic prostate cancer. N Engl J Med. 2019;381:121–131. doi:10.1056/NEJMoa1903835
   PubMed Web of Science ®Google Scholar
• Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. 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. PMID: 31329516; PMCID: PMC6839905. doi:10.1200/JCO.19.00799
   PubMed Web of Science ®Google Scholar
• Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381:13–24. doi:10.1056/NEJMoa1903307
   PubMed Web of Science ®Google Scholar
• Fizazi K, Foulon S, Carles J. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomized, phase 3 student with a 2x2 factorial design. Lancet. 2022;399(10336):1695–1707. doi:10.1016/S0140-6736(22)00367-1
   PubMed Web of Science ®Google Scholar
• Smith MR, Hussain M, Saad F. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. 2022;386:1132–1142. doi:10.1056/NEJMoa2119115
   PubMed Web of Science ®Google Scholar
• 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;351:1502–1512. doi:10.1056/NEJMoa040720
   PubMed Web of Science ®Google Scholar
• 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;351:1513–1520. doi:10.1056/NEJMoa041318
   PubMed Web of Science ®Google Scholar
• Gravis G, Boher JM, Joly F, et al. Androgen deprivation therapy (ADT) plus docetaxel versus ADT alone in metastatic non castrate prostate cancer: impact of metastatic burden and long-term survival analysis of the randomized phase 3 GETUG-AFU15 trial. Eur Urol. 2016;70(2):256–262. doi:10.1016/j.eururo.2015.11.005
   PubMed Web of Science ®Google Scholar
• Kyriakopoulos C, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial. J Clin Oncol. 2018;36(11):1080–1087. doi:10.1200/JCO.2017.75.3657
   PubMed Web of Science ®Google Scholar
• Puente J, Grande E, Medina A, Maroto P, Lainez N, Arranz JA. Docetaxel in prostate cancer: a familiar face as the new standard in a hormone-sensitive setting. Ther Adv Med Oncol. 2017;9(5):307–318. PMID: 28529548; PMCID: PMC5424862. doi:10.1177/1758834017692779
   PubMed Web of Science ®Google Scholar
• Mottet N, van den Bergh RCN, Briers E, et al.: EAU Guidelines. Presented at the EAU Annual Congress Copenhagen, Denmark. Arnhem, The Netherlands: EAU Guidelines Office; 2018. Available from: https://uroweb.org/wp-content/uploads/EAU-ESUR-ESTRO-SIOG-Guidelines-on-Prostate-Cancer-large-text-V2.pdf. Accessed November 04, 2023.
   Google Scholar
• Ryan CJ, Smith MR, Fizazi K, et al. 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;16:152–160. doi:10.1016/S1470-2045(14)71205-7
   PubMed Web of Science ®Google Scholar
• de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364:1995–2005. doi:10.1056/NEJMoa1014618
   PubMed Web of Science ®Google Scholar
• James ND, de Bono JS, Spears MR. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med. 2017;377:338–351. doi:10.1056/NEJMoa1702900
   PubMed Web of Science ®Google Scholar
• Hoyle AP, Ali A, James ND, et al. Abiraterone in “high-” and “low-risk” metastatic hormone-sensitive prostate cancer. Eur Urol. 2019;76(6):719–728. doi:10.1016/j.eururo.2019.08.006
   PubMed Web of Science ®Google Scholar
• Scher HI, Fizazi K, Saad F, et al.; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187–1197. doi:10.1056/NEJMoa1207506
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Smith MR, Saad F, Chowdhury SO, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79(1):150–158. doi:10.1016/j.eururo.2020.08.011
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Amstrong A, Azad A, Iguchi T. Improved survival with enzalutamide in patients with metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2022;40(15):1616–1622. doi:10.1200/JCO.22.00193
   PubMed Web of Science ®Google Scholar
• Chi KN, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study. J Clin Oncol. 2021;39(20):2294–2303. doi:10.1200/JCO.20.03488
   PubMed Web of Science ®Google Scholar
• Schaeffer EM, Srinivas S, Adra N, et al. NCCN guidelines® insights: prostate cancer, version 1.2023. J Natl Compr Canc Netw. 2022;20(12):1288–1298. doi:10.6004/jnccn.2022.0063
   PubMed Web of Science ®Google Scholar
• Riaz I, Naqvi S, He H, et al. First-line systemic treatment options for metastatic castration-sensitive prostate cancer: a living systematic review and network meta-analysis. JAMA Oncol. 2023;9(5):635–645. doi:10.1001/jamaoncol.2022.7762
   PubMed Web of Science ®Google Scholar
• Vale C, Fisher D, Godolphin P, et al. Which patients with metastatic hormone-sensitive prostate cancer benefit from docetaxel: a systematic review and meta-analysis of individual participant data from randomized trials. Lancet. 2021;24(7):783–797. doi:10.1016/S1470-2045(23)00230-9
   Web of Science ®Google Scholar
• Burdett S, Boevé L, Ingleby F, et al. Prostate radiotherapy for metastatic hormone-sensitive prostate cancer: a STOPCAP systematic review and meta-analysis. Eur Urol. 2019;1(76):115–124. doi:10.1016/j.eururo.2019.02.003
   Google Scholar
• Sartor A, Tagawa S, Saad F, et al. PSMAddition: a Phase 3 trial to compare treatment with 177Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in patients with metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2022;40(6_suppl):TPS210–TPS210. doi:10.1200/JCO.2022.40.6_suppl.TPS210
   Web of Science ®Google Scholar
• Fizazi K, George D, Santis M, et al. A phase III trial of capivasertib and Abiraterone versus placebo and Abiraterone in patients with de novo metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency (CAPItello-281). J Clin Oncol. 2021;39:TPS178–TPS178. doi:10.1200/JCO.2021.39.6_suppl.TPS178
   Web of Science ®Google Scholar
• Smith MR, Nobuaki N, McKay R, et al. CYCLONE 3: a phase 3, randomized, double-blind, placebo-controlled study of abemaciclib in combination with Abiraterone plus prednisone in men with high-risk, metastatic, hormone-sensitive prostate cancer (mHSPC). J Clin Oncol. 2023;41:TPS289–TPS289. doi:10.1200/JCO.2023.41.6_suppl.TPS289
   Web of Science ®Google Scholar
• Gratzke C, Kwiatkowski M, De Giorgi U, et al. KEYNOTE-991: pembrolizumab plus enzalutamide and androgen deprivation for metastatic hormone-sensitive prostate cancer. Future Oncol. 2023. PMID: 36705526. doi:10.2217/fon-2022-0776
   PubMed Web of Science ®Google Scholar
• Rathkopf D, Chi K, Olmos D. AMPLITIDE: a study of niraparib in combination with Abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). J Clin Oncol. 2021;39:TPS176–TPS176.
   Web of Science ®Google Scholar
• Agarwal N, Azad A, Fizazi K, et al. TALAPRO-3: a phase 3, double-blind, randomized study of enzalutamide (ENZA) plus talazoparib (TALA) versus placebo plus enza in patients with DDR gene mutated metastatic castration-sensitive prostate cancer (mCSPC). J Clin Oncol. 2022;40(6_suppl):3301–3309. doi:10.1200/JCO.2022.40.6_suppl.TPS221
   PubMed Web of Science ®Google Scholar
• Johann de Bono MB, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer. N Eng J Med. 2020;382:2091–2102. doi:10.1056/NEJMoa1911440
   PubMed Web of Science ®Google Scholar
• Fizazi K, Piulats J, Reaume N. Rucaparib or physician’s choice in metastatic prostate cancer. N Eng J Med. 2023;388:719–732. doi:10.1056/NEJMoa2214676
   PubMed Web of Science ®Google Scholar
• Abida W, Campbell D, Patnaik A, et al. Rucaparib for the treatment of metastatic castration-resistant prostate cancer associated with a DNA damage repair gene alteration: final results from the phase 2 TRITON2 study. Eur Urol. 2023;84(3):321–330. doi:10.1016/j.eururo.2023.05.021
   PubMed Web of Science ®Google Scholar
• Smith M, Scher H, Sandhu S, et al. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022;23(3):362–373. doi:10.1016/S1470-2045(21)00757-9
   PubMed Web of Science ®Google Scholar
• de Bono J, Mehra N, Scagliotti G, et al. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol. 2021;22(9):1250–1264. doi:10.1016/S1470-2045(21)00376-4
   PubMed Web of Science ®Google Scholar
• Clarke N, Armstrong A, Thiery-Vuillemin A, et al. Abiraterone and Olaparib for metastatic castration-resistant prostate cancer. NEJM Evid. 2022;1(9). doi:10.1056/EVIDoa2200043
   Google Scholar
• Chi K, Rathkopf D, Smith M, et al. Niraparib and Abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol. 2023;41(18):3339–3351. doi:10.1200/JCO.22.01649
   PubMed Web of Science ®Google Scholar
• Agarwal N, Azad A, Carles J, et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet. 2023;402(10398):291–303. doi:10.1016/S0140-6736(23)01055-3
   PubMed Web of Science ®Google Scholar
• Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival and metastatic prostate cancer. N Engl J Med. 2013;369:213–223. doi:10.1056/NEJMoa1213755
   PubMed Web of Science ®Google Scholar
• Hofman M, Emmett L, Sandhu S, et al. [177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomized, open-label, phase 2 trial. Lancet. 2021;397(10276):797–804.
   PubMed Web of Science ®Google Scholar
• Hofman M, Emmet 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
   Google Scholar