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Cited by 55Prostate Cancer Treatment and ResearchPI3K/AKT/mTOR signaling in cancerAdvanced Breast Cancer Therapies

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Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study

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Fizazi, K., Clarke, N.W., De Santis, M., Uemura, H., Fay, A.P., Karadurmus, N., Kwiatkowski, M., Alvarez-Fernandez, C., Jiang, S., Sotelo, M., Parslow, D., Oliveira, N., Kwon, T.G., Ye, D., Boudewijns, S., Danchaivijitr, P., Rooney, C., Gresty, C., Yeste-Velasco, M., Logan, J., George, D.J., Salvatierra, Alejandro, Korbenfeld, Ernesto, Galanternik, Fernando, Garbaos, Gabriel, Cutuli, Hector, Cutuli, Hernan, Sade, Juan, Varela, Mirta, Daniele, Sergio, Chernobilsky, Victor, Stevanovic, Amanda, Crumbaker, Megan, Morris, Michelle, Oliveira, Niara, Zielinski, Robert, Luger, Ferdinand, Loidl, Wolfgang, Bauernhofer, Thomas, Kunit, Thomas, Sautois, Brieuc, Vulsteke, Christof, Lesage, Karl, Lumen, Nicolaas, Chanza, Nieves Martinez, Sideris, Spyridon, Godoy, Antonio, Kann, Ariel, Mello, Bruno, Fernandes, Bruno, Kussumoto, Célio, Joseph de Padua, Charles, Anjos, Gabriel dos, Martins da Trindade, Karine, Tiscoski, Katsuki, Escovar, Carlos, Colli, Leandro, Antunes, Luis, Girotto, Gustavo, Ferreira, Luiza, Freitas, Marcelo, Beato, Patricia, Padoan, Monica Luciana, Domingues, Pedro, Velho, Pedro, Tomova, Antoaneta, Kurteva, Galina, Konsoulova-Kirova, Assia, Konsulova, Asya, Kalev, Dimitar, Arabadjiev, Jelyazko, Tsenov, Mitko, Atanasova, Mariana, Chilingirova, Nataliya, Minchev, Velko, Kanarev, Vladimir, Rose, April, Ferrario, Cristiano, Finch, Daygen, Jiang, Di Maria, Hansen, Aaron, Chi, Kim, Iafolla, Marco, Kolinsky, Michael, Zalewski, Pawel, Yip, Steven, Emmenegger, Urban, Salazar, Anibal, Loredo, Eugenia, Zwenger, Ariel, Garrido, Marcelo, Orio, Mario, Burotto, Mauricio, Han, Bangmin, Wu, Bin, Chunxi wang, Zhang, Dahong, Ye, Dingwei, Zhou, Fangjian, Wang, Gongxian, Luo, Guangheng, Li, Hanzhong, Zeng, Hao, Luo, Hong, Guo, Hongqian, Guo, Jianming, Chen, Jimin, Bai-ye, Jin, Xie, Keji, Li, Lei, Shi, Lei, Zhou, Liqun, Chen, Minfeng, Xue, Xueyi, Xu, Ning, Ma, Qi, Wang, Qilin, Zou, Qing, Wang, Qingwei, Wang, Shaogang, Jiang, Shusuan, Han, Weiqing, Zheng, Song, Yang, Tie-jun, Tan, Wanlong, Chen, Wei, Xue, Wei, Wang, Xiaolin, Tian, Ye, Liao, Yong, Wang, Yong, Yang, Yong, Chen, Zhiwen, Chen, Zhiwei, Dvorák, Jan, Katolicka, Jana, Petera, Jiri, Smakal, Martin, Matouskova, Michaela, Holeckova, Petra, Borchiellini, Delphine, Tosi, Diego, Annic, Josselin, Schlurmann, Friederike, Roubaud, Guilhem, Gravis, Gwenaelle, Fizazi, Karim, Bennamoun, Mostefa, Barthelemy, Philippe, Ratta, Raffaele, Mathieu, Romain, Tartas, Sophie, Maurina, Tristan, Thiery-Vuillemin, Antoine, Hellmis, Eva, Roghmann, Florian, De Santis, Maria, Augustin, Marinela, Bögemann, Martin, Schürmann, Miguel Garcia, Spiegelhalder, Philipp, Feyerabend, Susan, Steuber, Thomas, Kin Cheng, Ashley Chi, Ng, Bryan, Wong, Kenneth, Siu, Steven, Kapoor, Akhil, Jain, Amit, Kumar, Anil, Batra, Atul, James, Francis, Goyal, Gautam, Baxi, Hemang, Udupa, Karthik, Subramanian, Kirushna Kosananm, Mehta, Prashant, Agarwal, Amit, Rajpurohit, Sajjan, Thungappa, Satheesh, Prasad, Saurabh, Dabkara, Deepak, Roy, Somnath, Rawal, Sudhir, Talreja, Vikas, Peer, Avivit, Rosenbaum, Eli, Kushnir, Igal, Levartovsky, Meital, Leibowitz, Raya, Frank, Stephen, Kawakami, Satoru, Yano, Akihiro, Fukasawa, Satoshi, Komaru, Atsushi, Tabata, Kenichi, Koguchi, Dai, Motoyama, Daisuke, Miyake, Hideaki, Matsushita, Kazuhito, Shimizu, Fumitaka, Kinoshita, Hidefumi, Kikukawa, Hiroaki, Uemura, Hiroji, Adachi, Hisanobu, Kawamura, Sadahumi, Yoshimura, Kazuhiro, Kobayashi, Kazuki, Nishimura, Kazuo, Iijima, Kazuyoshi, Nakamura, Kazuyoshi, Miyata, Yasuyoshi, Mitsunari, Kensuke, Sakai, Hideki, Kobayashi, Takashi, Masui, Kimihiko, Matsumoto, Hiroaki, Shiraishi, Koji, Izumi, Kouji, Shiota, Masaki, Miyajima, Akira, Hasegawa, Masanori, Shimizu, Nobuaki, Hasumi, Masaru, Sugimoto, Mikio, Hashimoto, Yasuhiro, Fujita, Naoki, Matsumoto, Ryuji, Sakamoto, Shinichi, Inoue, Takahiro, Saika, Takashi, Kosaka, Takeo, Kawakita, Mutsushi, Yamasaki, Toshinari, Nishikimi, Toshinori, Shin, Toshitaka, Terada, Naoki, Kamoto, Toshiyuki, Obara, Wataru, Fujimoto, Kiyohide, Nakai, Yasushi, Naito, Yushi, Kato, Masashi, Jiménez, Emmanuel de la Mora, Perez, Hector Diaz, Lopez, Lorben, Contreras Contreras, Luis Alberto, Villanueva, Omar Zayas, Perez, Perla, Bergman, Andre, Hunting, Cornelis (Jarmo), Houtsma, Daniel, van den Berg, Hendrik, van Alphen, Robbert, Boudewijns, Steve, Muñante, Bruno, Aliaga, Carlos, Acevedo, Carmen, Lopez, Jose Revilla, Sotelo, Miguel, Bermudez, Vanessa, Morante, Zaida, Lui, Arthur Gregory, Alipat, Jandre Jomar, Letran, Jason, Tadeo, Karen, Batucan, Marlo Vir, Li, Rubi, de Guzman, Rudolfo, Żurawski, Bogdan, Bar-Letkiewicz, Ilona, Skoneczna, Iwona, Kuć, Kamil, Kubiatowski, Tomasz, Żukowska, Karolina, Bodnar, Lubomir, Ułańska, Małgorzata, Kwiatkowski, Mariusz, Wiechno, Pawel, Adamczyk, Przemysław, Zaucha, Renata, Kholtobin, Denis, Gornastolev, Dmitry, Karnaukhov, Ivan, Osipov, Mikhail, Belogortsev, Igor, Kislov, Nikolay, Gafanov, Rustem, Mishugin, Sergey, Kozlov, Vadim, Kollarik, Boris, Goncalves, Frederico, Mincik, Ivan, Kliment, Jan, Brezovsky, Marek, Polak, Richard, Sokol, Roman, Jacobs, Conrad, Coetzee, Corlia, Burger, Henriette, Malan, Jorn, Chabane, Khabane, Mathiba, Rofhiwa, Tshabalala, Dineo, Marais-Nieman, Rouchelle, Mayet, Yusuf, Kwak, Cheol, Joung, Jae-Young, Lee, Ji Youl, Hong, Jun Hyuk, Byun, Seok-Soo, Jeon, Seong Soo, Kwon, Tae Gyun, Choi, Young Deuk, Pous, Albert Font, Echaburu, Juan Virizuela, Camacho Mejias, Alberto Sanchez, De Liano, Alfonso Gomez, Gordoa, Teresa Alonso, Granados, Alvaro Ruiz, Alvarez-Fernandez, Carlos, Gauna, Daniel Castellano, Martínez, Ignacio Durán, Vazquez, Javier Puente, Arranz Arija, José Ángel, Rey, Jose Maroto, Huang, Chi-Ping, Meng, En, Chung, Hsiao-Jen, Lin, Jen-Tai, Huang, Kuan-Hua, Pang, See-Tong, Wu, Wen-Jeng, Ou, Yen-Chuan, Pripatnanont, Choosak, Raunroadroong, Nilubol, Wanchaijiraboon, Passakorn, Chansriwong, Phichai, Danchaivijitr, Pongwut, Suksombooncharoen, Thatthan, Attawettayanon, Worapat, Chalieopanyarwong, Virote, Coskun, Hasan Senol, Tatli, Ali Murat, Arslan, Cagatay, Gokmen, Erhan, Inanc, Mevlude, Demir, Lütfiye, Dincer, Murat, Demir, Metin, Ozguroglu, Mustafa, Karadurmus, Nuri, Urun, Yuksel, Reid, Alison, Choudhury, Ananya, Mazhar, Danish, Parslow, Dominique, Palaniappan, Nachi, Staffurth, John, Mehta, Sheel, Patnaik, Akash, Dasgupta, Anirudha, Kalebasty, Arash Rezazadeh, Hussain, Arif, Hussain, Arif, Berman, Barry, Abesada-Terk, Guillermo, Gartrell, Benjamin, Redfern, Charles, George, Christopher, Pieczonka, Christopher, Dunshee, Curtis, George, Daniel, Geynisman, Daniel, Cahn, David, Slater, Dennis, Arrowsmith, Edward, Heath, Elisabeth, Guancial, Elizabeth, Batts, Eric, Lang, Joshua, Kernen, Kenneth, Karsh, Lawrence, Appleman, Leonard, Fleming, Mark, Kochenderfer, Mark, Sorbellini, Maximiliano, Bhangoo, Munveer, Shore, Neal, Monk, Paul, Sieber, Paul, Miocinovic, Ranko, Zhao, Song, Savage, Stephen, Smith, Stephen, Vu, Hai, Nguyen, Ba, Nguyen, Hieu, Nguyen, Hoa, Ngo, Thai, Tran, Hai, Nguyen, Yen·2026·Annals of Oncology
DOI 10.1016/j.annonc.2025.10.004
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Abstract

BACKGROUND: In metastatic hormone-sensitive prostate cancer (mHSPC), phosphatase and tensin homolog (PTEN) deficiency results in phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT) pathway activation, providing an independent proliferative drive, which cannot be suppressed by androgen receptor pathway inhibitors (ARPIs), resulting in worse outcomes. Dual inhibition of PI3K/AKT and AR pathways with capivasertib and abiraterone may delay progression and improve disease outcomes. PATIENTS AND METHODS: In CAPItello-281 (NCT04493853), patients with PTEN-deficient mHSPC (diagnostic cut-off: ≥90% viable malignant cells with no specific cytoplasmic PTEN immunohistochemistry staining) received capivasertib or placebo (1 : 1) plus abiraterone, prednisone/prednisolone, and androgen deprivation therapy (ADT). The primary endpoint was investigator-assessed radiographic progression-free survival (rPFS); overall survival (OS) was a key secondary endpoint. Post hoc exploratory subgroups at increasing PTEN cut-off thresholds were also assessed. RESULTS: 25.3% (1519/6003) of patients with valid tumor test results had PTEN-deficient tumors. In the randomized PTEN-deficient population, a statistically significant improvement in rPFS was observed with capivasertib plus abiraterone (n = 507, median 33.2 months) versus placebo plus abiraterone [n = 505, 25.7 months; hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.66-0.98, P = 0.034]. Post hoc rPFS analyses for loss of PTEN cut-offs of ≥95%, ≥99%, and 100% showed that the capivasertib plus abiraterone arm performed consistently across cut-offs, but the placebo plus abiraterone arm performed progressively worse as the cut-off for the degree of PTEN loss was increased, resulting in a numerically improved treatment effect. In the overall population studied, the HR for OS (26.4% maturity) was 0.90, 95% CI 0.71-1.15, P = 0.401. The most common adverse events (AEs) for capivasertib plus abiraterone were diarrhea (51.9%; 8.0% placebo plus abiraterone), hyperglycemia (38.0%; 12.9%), and rash (35.4%; 7.0%). Deaths associated with an AE were reported in 36 (7.2%) and 26 (5.2%) patients in the capivasertib plus abiraterone and placebo plus abiraterone arms, respectively. CONCLUSIONS: Capivasertib plus abiraterone improves rPFS versus placebo plus abiraterone in PTEN-deficient mHSPC, on a background of ADT, with a 7.5-month improvement in median rPFS. AE profile was consistent with that of the individual agents. Patients with PTEN-deficient mHSPC benefit from dual blockade of the PI3K/AKT and AR pathways with capivasertib plus abiraterone.

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Fizazi, K., Clarke, N. W., De Santis, M., Uemura, H., Fay, A. P., Karadurmus, N., Kwiatkowski, M., Alvarez-Fernandez, C., Jiang, S., Sotelo, M., Parslow, D., Oliveira, N., Kwon, T. G., Ye, D., Boudewijns, S., Danchaivijitr, P., Rooney, C., Gresty, C., Yeste-Velasco, M., Logan, J., George, D. J., Salvatierra, A., Korbenfeld, E., Galanternik, F., Garbaos, G., Cutuli, H., Cutuli, H., Sade, J., Varela, M., Daniele, S., Chernobilsky, V., Stevanovic, A., Crumbaker, M., Morris, M., Oliveira, N., Zielinski, R., Luger, F., Loidl, W., Bauernhofer, T., Kunit, T., Sautois, B., Vulsteke, C., Lesage, K., Lumen, N., Chanza, N. M., Sideris, S., Godoy, A., Kann, A., Mello, B., Fernandes, B., Kussumoto, C., Joseph de Padua, C., Anjos, G. D., Martins da Trindade, K., Tiscoski, K., Escovar, C., Colli, L., Antunes, L., Girotto, G., Ferreira, L., Freitas, M., Beato, P., Padoan, M. L., Domingues, P., Velho, P., Tomova, A., Kurteva, G., Konsoulova-Kirova, A., Konsulova, A., Kalev, D., Arabadjiev, J., Tsenov, M., Atanasova, M., Chilingirova, N., Minchev, V., Kanarev, V., Rose, A., Ferrario, C., Finch, D., Jiang, D. M., Hansen, A., Chi, K., Iafolla, M., Kolinsky, M., Zalewski, P., Yip, S., Emmenegger, U., Salazar, A., Loredo, E., Zwenger, A., Garrido, M., Orio, M., Burotto, M., Han, B., Wu, B., wang, C., Zhang, D., Ye, D., Zhou, F., Wang, G., Luo, G., Li, H., Zeng, H., Luo, H., Guo, H., Guo, J., Chen, J., Bai-ye, J., Xie, K., Li, L., Shi, L., Zhou, L., Chen, M., Xue, X., Xu, N., Ma, Q., Wang, Q., Zou, Q., Wang, Q., Wang, S., Jiang, S., Han, W., Zheng, S., Yang, T.-J., Tan, W., Chen, W., Xue, W., Wang, X., Tian, Y., Liao, Y., Wang, Y., Yang, Y., Chen, Z., Chen, Z., Dvorák, J., Katolicka, J., Petera, J., Smakal, M., Matouskova, M., Holeckova, P., Borchiellini, D., Tosi, D., Annic, J., Schlurmann, F., Roubaud, G., Gravis, G., Fizazi, K., Bennamoun, M., Barthelemy, P., Ratta, R., Mathieu, R., Tartas, S., Maurina, T., Thiery-Vuillemin, A., Hellmis, E., Roghmann, F., De Santis, M., Augustin, M., Bögemann, M., Schürmann, M. G., Spiegelhalder, P., Feyerabend, S., Steuber, T., Kin Cheng, A. C., Ng, B., Wong, K., Siu, S., Kapoor, A., Jain, A., Kumar, A., Batra, A., James, F., Goyal, G., Baxi, H., Udupa, K., Subramanian, K. K., Mehta, P., Agarwal, A., Rajpurohit, S., Thungappa, S., Prasad, S., Dabkara, D., Roy, S., Rawal, S., Talreja, V., Peer, A., Rosenbaum, E., Kushnir, I., Levartovsky, M., Leibowitz, R., Frank, S., Kawakami, S., Yano, A., Fukasawa, S., Komaru, A., Tabata, K., Koguchi, D., Motoyama, D., Miyake, H., Matsushita, K., Shimizu, F., Kinoshita, H., Kikukawa, H., Uemura, H., Adachi, H., Kawamura, S., Yoshimura, K., Kobayashi, K., Nishimura, K., Iijima, K., Nakamura, K., Miyata, Y., Mitsunari, K., Sakai, H., Kobayashi, T., Masui, K., Matsumoto, H., Shiraishi, K., Izumi, K., Shiota, M., Miyajima, A., Hasegawa, M., Shimizu, N., Hasumi, M., Sugimoto, M., Hashimoto, Y., Fujita, N., Matsumoto, R., Sakamoto, S., Inoue, T., Saika, T., Kosaka, T., Kawakita, M., Yamasaki, T., Nishikimi, T., Shin, T., Terada, N., Kamoto, T., Obara, W., Fujimoto, K., Nakai, Y., Naito, Y., Kato, M., Jiménez, E. D. L. M., Perez, H. D., Lopez, L., Contreras Contreras, L. A., Villanueva, O. Z., Perez, P., Bergman, A., Hunting, C. (., Houtsma, D., van den Berg, H., van Alphen, R., Boudewijns, S., Muñante, B., Aliaga, C., Acevedo, C., Lopez, J. R., Sotelo, M., Bermudez, V., Morante, Z., Lui, A. G., Alipat, J. J., Letran, J., Tadeo, K., Batucan, M. V., Li, R., de Guzman, R., Żurawski, B., Bar-Letkiewicz, I., Skoneczna, I., Kuć, K., Kubiatowski, T., Żukowska, K., Bodnar, L., Ułańska, M., Kwiatkowski, M., Wiechno, P., Adamczyk, P., Zaucha, R., Kholtobin, D., Gornastolev, D., Karnaukhov, I., Osipov, M., Belogortsev, I., Kislov, N., Gafanov, R., Mishugin, S., Kozlov, V., Kollarik, B., Goncalves, F., Mincik, I., Kliment, J., Brezovsky, M., Polak, R., Sokol, R., Jacobs, C., Coetzee, C., Burger, H., Malan, J., Chabane, K., Mathiba, R., Tshabalala, D., Marais-Nieman, R., Mayet, Y., Kwak, C., Joung, J.-Y., Lee, J. Y., Hong, J. H., Byun, S.-S., Jeon, S. S., Kwon, T. G., Choi, Y. D., Pous, A. F., Echaburu, J. V., Camacho Mejias, A. S., De Liano, A. G., Gordoa, T. A., Granados, A. 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Affiliations
  • University of Manchester (GB)
  • Kindai University Hospital (JP)
  • Pontifícia Universidade Católica do Rio Grande do Sul (BR)
  • Derriford Hospital (GB)
  • Kyungpook National University Chilgok Hospital (KR)
  • AstraZeneca (United Kingdom) (GB)
  • AstraZeneca (United States) (US)
  • Duke Cancer Institute (US)
  • Hospital Universitario Central de Asturias (ES)
  • Sağlık Bilimleri Üniversitesi (TR)
ORCID
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2026-01
Volume
37
Issue
1
Pages
53-68
ISSN
0923-7534 (ISSN-L)
DOI
10.1016/j.annonc.2025.10.004
OpenAlex
W4415331967
Cited by
55
References
1
Citations by year
2026: 48
FWCI
36.16
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Oncology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
AstraZeneca PLC
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › PI3K/AKT/mTOR signaling in cancer
  • Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
Keywords
capivasertib, abiraterone, PTEN loss, metastatic hormone-sensitive prostate cancer, PI3K/Akt signaling, androgen receptor pathway, dual pathway inhibition, progression-free survival, overall survival, androgen deprivation therapy, predictive biomarkers, treatment effect heterogeneity
MeSH terms
Progression-Free Survival, Aged, Aged, 80 and over, Androgen Antagonists, Androstenes, Antineoplastic Combined Chemotherapy Protocols, Double-Blind Method, Humans, Male, Middle Aged, Prostatic Neoplasms, Pyrazoles, Pyrimidines, Pyrroles, PTEN Phosphohydrolase

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