The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy

Summary

The purpose of this study is to assess the impact of medication timing adjustment on the effect of novel hormonal therapy (NHT) agents in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The half of the patients will receive NHT agents in the morning, and the other half will receive NHT agents in the evening.

Timeline

Start

2024-08

Primary completion

2025-03

Completion

2025-12

Publications

• Background Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
• Background Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
• Background Mottet N, Cornford P, Vanden Bergh RCN, et al. EAU-EANM-ESTRO-ESUR-ISUP_SIOG guidelines on prostate cancer. (2023).
• Background Schaeffer EM, Srinivas S, Adra N, An Y, Barocas D, Bitting R, Bryce A, Chapin B, Cheng HH, D'Amico AV, Desai N, Dorff T, Eastham JA, Farrington TA, Gao X, Gupta S, Guzzo T, Ippolito JE, Kuettel MR, Lang JM, Lotan T, McKay RR, Morgan T, Netto G, Pow-Sang JM, Reiter R, Roach M, Robin T, Rosenfeld S, Shabsigh A, Spratt D, Teply BA, Tward J, Valicenti R, Wong JK, Shead DA, Snedeker J, Freedman-Cass DA. Prostate Cancer, Version 4.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023 Oct;21(10):1067-1096. doi: 10.6004/jnccn.2023.0050.
• Background Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. 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 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.
• Background Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.
• Background Zhou T, Zeng SX, Ye DW, Wei Q, Zhang X, Huang YR, Ye ZQ, Yang Y, Zhang W, Tian Y, Zhou FJ, Jie J, Chen SP, Sun Y, Xie LP, Yao X, Na YQ, Sun YH. A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer. PLoS One. 2015 Jan 27;10(1):e0117002. doi: 10.1371/journal.pone.0117002. eCollection 2015.
• Background Ozturk N, Ozturk D, Kavakli IH, Okyar A. Molecular Aspects of Circadian Pharmacology and Relevance for Cancer Chronotherapy. Int J Mol Sci. 2017 Oct 17;18(10):2168. doi: 10.3390/ijms18102168.
• Background Patke A, Young MW, Axelrod S. Molecular mechanisms and physiological importance of circadian rhythms. Nat Rev Mol Cell Biol. 2020 Feb;21(2):67-84. doi: 10.1038/s41580-019-0179-2. Epub 2019 Nov 25.
• Background Rosenwasser AM, Turek FW. Neurobiology of Circadian Rhythm Regulation. Sleep Med Clin. 2015 Dec;10(4):403-12. doi: 10.1016/j.jsmc.2015.08.003. Epub 2015 Sep 11.
• Background Hastings MH, Maywood ES, Brancaccio M. Generation of circadian rhythms in the suprachiasmatic nucleus. Nat Rev Neurosci. 2018 Aug;19(8):453-469. doi: 10.1038/s41583-018-0026-z.
• Background Turcu AF, Zhao L, Chen X, Yang R, Rege J, Rainey WE, Veldhuis JD, Auchus RJ. Circadian rhythms of 11-oxygenated C19 steroids and ∆5-steroid sulfates in healthy men. Eur J Endocrinol. 2021 Aug 27;185(4):K1-K6. doi: 10.1530/EJE-21-0348.
• Background Rivard GE, Infante-Rivard C, Hoyoux C, Champagne J. Maintenance chemotherapy for childhood acute lymphoblastic leukaemia: better in the evening. Lancet. 1985 Dec 7;2(8467):1264-6. doi: 10.1016/s0140-6736(85)91551-x.
• Background Rivard GE, Infante-Rivard C, Dresse MF, Leclerc JM, Champagne J. Circadian time-dependent response of childhood lymphoblastic leukemia to chemotherapy: a long-term follow-up study of survival. Chronobiol Int. 1993 Jun;10(3):201-4. doi: 10.3109/07420529309073888.
• Background Qian DC, Kleber T, Brammer B, Xu KM, Switchenko JM, Janopaul-Naylor JR, Zhong J, Yushak ML, Harvey RD, Paulos CM, Lawson DH, Khan MK, Kudchadkar RR, Buchwald ZS. Effect of immunotherapy time-of-day infusion on overall survival among patients with advanced melanoma in the USA (MEMOIR): a propensity score-matched analysis of a single-centre, longitudinal study. Lancet Oncol. 2021 Dec;22(12):1777-1786. doi: 10.1016/S1470-2045(21)00546-5. Epub 2021 Nov 12.
• Background Ryan CJ, Smith MR, Fong L, Rosenberg JE, Kantoff P, Raynaud F, Martins V, Lee G, Kheoh T, Kim J, Molina A, Small EJ. Phase I clinical trial of the CYP17 inhibitor abiraterone acetate demonstrating clinical activity in patients with castration-resistant prostate cancer who received prior ketoconazole therapy. J Clin Oncol. 2010 Mar 20;28(9):1481-8. doi: 10.1200/JCO.2009.24.1281. Epub 2010 Feb 16.
• Background Hong JH. Pharmacokinetic/pharmacodynamic drug evaluation of enzalutamide for treating prostate cancer. Expert Opin Drug Metab Toxicol. 2018 Mar;14(3):361-369. doi: 10.1080/17425255.2018.1440288. Epub 2018 Feb 13.

Drugs

Indications