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. 2024 Oct 18;13(20):6221.
doi: 10.3390/jcm13206221.

Ultralow Prostate-Specific Antigen (PSA) Levels and Improved Oncological Outcomes in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients Treated with Apalutamide: A Real-World Multicentre Study

Alicia López-Abad  1 , Mario Belmonte  2 , Miguel Ramírez Backhaus  3 , Gerardo Server Gómez  4 , Enrique Cao Avellaneda  1 , Cristóbal Moreno Alarcón  1 , Pedro López Cubillana  1 , Pablo Yago Giménez  1 , Pedro de Pablos Rodríguez  3 , María José Juan Fita  3 , Miguel Ángel Climent Durán  3 , Iris Guardiola Ruiz  4 , Natalia Vidal Crespo  4 , Juan Moreno Avilés  4 , Pablo Luis Guzmán Martínez-Valls  1 , Pedro Ángel López González  1
Affiliations

Ultralow Prostate-Specific Antigen (PSA) Levels and Improved Oncological Outcomes in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients Treated with Apalutamide: A Real-World Multicentre Study

Alicia López-Abad et al. J Clin Med. .

Abstract

Background/Objectives: Androgen receptor-targeted agents have significantly improved the prognosis of metastatic hormone-sensitive prostate cancer (mHSPC). Prostate-specific antigen (PSA) levels are key prognostic markers, with rapid and deep reductions associated with better outcomes. This study aims to assess the association between the new PSA cut-offs and survival in mHSPC patients treated with Apalutamide. Methods: We conducted a multicentre, retrospective analysis of mHSPC patients treated with Apalutamide between March 2021 and January 2023. Overall survival (OS) and radiographic progression-free survival (rFPS) were analyzed and stratified by the following PSA ranges: <0.02 ng/mL (ultralow), 0.02-0.2 ng/mL, and >0.2 ng/mL. Cox regression was applied to identify variables associated with OS and rPFS. Results: Among 193 patients, 34.2% had de novo mHSPC, with the majority classified as M1b. A total of 58.2% (110) of our cohort achieved ultralow PSA levels, with 20.6% between 0.02 and 0.2 ng/mL, and 21.2% of PSA levels > 0.2 ng/mL. Most patients reached ultralow PSA within six months. Low-volume, metachronous, and M1a subgroups displayed a higher prevalence of patients reaching ultralow PSA levels. At 18 months, OS was 100% in the ultralow PSA group, 94.4% for the 0.02-0.2 ng/mL group, and 67.7% in the >0.2 ng/mL group. Similarly, rPFS at 18 months was 100%, 93.5%, and 50.7%, respectively. Cox regression revealed that both ultralow PSA levels and ISUP grade had a significant impact on OS (HR of 8.256 and 0.164, respectively). For rPFS, only ultralow PSA levels had a significant impact (HR = 0.085). Conclusions: This real-world study of mHSPC patients treated with Apalutamide plus ADT revealed that achieving ultralow PSA levels is strongly associated with better oncological outcomes.

Keywords: PSA levels; metastatic hormone-sensitive prostate cancer; metastatic volume; prostate cancer; ultralow PSA.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Incidence of PSA < 0.2 ng/mL and ultralow PSA (<0.02 ng/mL) achieved in the cohort at various time points during the follow-up.
Figure 2
Figure 2
PSA ranges achieved in our cohort, stratified by metastasis volume (high volume vs. low volume).
Figure 3
Figure 3
PSA ranges achieved in our cohort, stratified by time of presentation (synchronous vs. metachronous).
Figure 4
Figure 4
PSA ranges achieved in our cohort, stratified by the metastasis localization (“M” staging: M1a, M1b, and M1c).
Figure 5
Figure 5
Kaplan–Meier survival curve for OS (a) and rPFS (b) by PSA ranges.
See this image and copyright information in PMC

References

    1. Pagliarulo V., Bracarda S., Eisenberger M.A., Mottet N., Schröder F.H., Sternberg C.N., Studer U.E. Contemporary role of androgen deprivation therapy for prostate cancer. Eur. Urol. 2012;61:11–25. doi: 10.1016/j.eururo.2011.08.026. - DOI - PMC - PubMed
    1. Armstrong A.J., Szmulewitz R.Z., Petrylak D.P., Holzbeierlein J., Villers A., Azad A., Alcaraz A., Alekseev B., Iguchi T., Shore N.D., 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. Off. J. Am. Soc. Clin. Oncol. 2019;37:2974–2986. doi: 10.1200/JCO.19.00799. - DOI - PMC - PubMed
    1. Chi K.N., Agarwal N., Bjartell A., Chung B.H., Pereira de Santana Gomes A.J., Given R., Soto Á.J., Merseburger A.S., Özgüroğlu M., Uemura H., et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N. Engl. J. Med. 2019;381:13–24. doi: 10.1056/NEJMoa1903307. - DOI - PubMed
    1. 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., et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N. Engl. J. Med. 2019;381:121–131. doi: 10.1056/NEJMoa1903835. - DOI - PubMed
    1. Fizazi K., Tran N., Fein L., Matsubara N., Rodriguez-Antolin A., Alekseev B.Y., Özgüroğlu M., Ye D., Feyerabend S., Protheroe A., et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N. Engl. J. Med. 2017;377:352–360. doi: 10.1056/NEJMoa1704174. - DOI - PubMed

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