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Clinical Trial
. 2022 Sep:173:317-326.
doi: 10.1016/j.ejca.2022.06.057. Epub 2022 Aug 16.

Radium-223 for patients with metastatic castration-resistant prostate cancer with asymptomatic bone metastases progressing on first-line abiraterone acetate or enzalutamide: A single-arm phase II trial

Joan Carles  1 , Teresa Alonso-Gordoa  2 , Begoña Mellado  3 , María J Méndez-Vidal  4 , Sergio Vázquez  5 , Aránzazu González-Del-Alba  6 , Josep M Piulats  7 , Pablo Borrega  8 , Enrique Gallardo  9 , Rafael Morales-Barrera  10 , Pilar Paredes  3 , Oscar Reig  3 , Carmen Garcías de España  11 , Ricardo Collado  11 , Teresa Bonfill  12 , Cristina Suárez  13 , Miguel Sampayo-Cordero  14 , Andrea Malfettone  14 , Javier Garde  14
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Free article
Clinical Trial

Radium-223 for patients with metastatic castration-resistant prostate cancer with asymptomatic bone metastases progressing on first-line abiraterone acetate or enzalutamide: A single-arm phase II trial

Joan Carles et al. Eur J Cancer. 2022 Sep.
Free article

Abstract

Purpose: The paper aims to evaluate the efficacy and safety of 223Ra in patients who progressed after first-line androgen deprivation therapy.

Patients and methods: EXCAAPE (NCT03002220) was a multicentre, single-arm, open-label, non-controlled phase IIa trial in 52 patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases who have progressed on abiraterone acetate or enzalutamide, up to six doses of 223Ra (55 kBq/kg of body weight per month). The primary end-point was radiographic progression-free survival (rPFS). Secondary end-points included rPFS based on androgen receptor splice variant 7 (AR-V7) expression in circulating tumour cells (CTCs), overall survival, and safety.

Results: Median rPFS was 5.5 months (95% CI 5.3-5.5). Median rPFS of patients with AR-V7(-) CTCs was longer than that of patients with AR-V7(+) CTCs (5.5 versus 2.2 months, respectively; P = 0.056). Median overall survival was 14.8 months (95% CI 11.2-not reached) and was significantly greater for AR-V7(-) patients than for AR-V7(+) patients (14.8 months versus 3.5 months, respectively; P < 0.01). 223Ra was well tolerated; anaemia and thrombocytopenia were the most common grade 3/4 adverse events (5.8% and 11.5%, respectively).

Conclusions: 223Ra seems to be a reasonable treatment for patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases progressing on novel hormonal therapy and had an acceptable safety profile.

Keywords: AR-V7; Bone metastases; Metastatic castration-resistant prostate cancer; Radium-223.

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Conflict of interest statement

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Bayer, Johnson &amp; Johnson, Bristol-Myers Squibb, Astellas Pharma, Pfizer, Sanofi, MSD, Roche, AstraZeneca, Asofarma, Ipsen, AB Science, Aragon Pharmaceuticals, Arog Pharmaceuticals, Aveo Pharmaceuticals INC, Blueprint Medicines Corporation, BN Immunotherapeutics INC, Boehringer Ingelheim España, S.A., , Clovis Oncology INC, Cougar Biotechnology INC, Deciphera Pharmaceuticals LLC, Exelixis INC, F. Hoffmann-La Roche LTD, Genentech INC, GlaxoSmithKline, Incyte Corporation, -Cilag, International NV, Karyopharm Therapeutics INC., EISAI, Merck Serono, Lilly, Novartis Pharmaceutical, S.A, Janssen, Eusa Pharma, Sanofi-Genzyme, Beigene, VCN biotech, and VCN biotech; Leurquin Mediolanum SAS, Pierre Fabre, Rovi, Daiichi Sankyo, Techdow, Leo Pharma, Menarini, Ferrer, Millennium Pharmaceuticals, INC, Medimmune, Nanobiotix SA, S.L.U, Puma Biotechnology, FJ Pharma LTD. II, Teva Pharma S.L.U., MEDSIR.

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