Triplet therapy with darolutamide and docetaxel for metastatic castration-sensitive prostate cancer: a multicenter real-world study.

Authors

Ibuki Tsuru, Satoru Taguchi, Ryo Tanaka, Taketo Kawai, Tomoyuki Kaneko, Yu Nakamura, Yoshifumi Miyauchi, Hayato Hoshina, Daisuke Obinata, Masashi Koshiba, Masashi Shiozaki, Jun Takahashi, Masato Kano, Akihiro Naito, Shohei Suda, Michio Noda, Nozomi Sugiyama, Takehiro Tanaka, Yukari Uemura, Jimpei Miyakawa, Jun Kamei, Shigenori Kakutani, Aya Niimi, Yuta Yamada, Yusuke Sato, Yukio Yamada, Hiroaki Nishimatsu, Takashi Murata, Sayuri Takahashi, Tappei Takada, Yoshiyuki Akiyama, Satoru Takahashi, Tetsuya Fujimura, Hiroshi Fukuhara, Tohru Nakagawa, Haruki Kume

Published in

Japanese journal of clinical oncology. Jul 09, 2026. Epub Jul 09, 2026.

Abstract

Triplet therapy with darolutamide and docetaxel has reshaped the treatment landscape of metastatic castration-sensitive prostate cancer (mCSPC). However, real-world evidence regarding its oncological outcomes and toxicity remains limited.
We retrospectively reviewed 112 consecutive patients with mCSPC who were treated with triplet therapy. A deep prostate-specific antigen (PSA) response was defined as a PSA level < 0.2 ng/ml or a ≥ 90% decline from baseline. Castration-resistant prostate cancer (CRPC)-free survival was used as the survival endpoint. Clinicopathological factors associated with CRPC-free survival were analysed using a Cox proportional hazards model. Treatment-related adverse events (AEs) were comprehensively documented by type and grade.
During a median follow-up of 17.1 months, 15 patients developed CRPC and four died of prostate cancer; 1-year CRPC-free survival and overall survival rates were 89.8% (95% confidence interval, 83.9%-96.0%) and 98.8% (96.5%-100%), respectively. A deep PSA response was achieved in 73.2% of patients (PSA nadir <0.2 ng/ml) and in 96.4% (PSA ≥ 90% decline). In both the univariable and multivariable analyses, no baseline factor was significantly associated with CRPC-free survival. Grade ≥ 3 hematologic AEs occurred in 75.0% of patients. Among the 31 patients who discontinued docetaxel, 26 discontinued due to non-hematologic AEs.
Triplet therapy demonstrated substantial clinical activity in real-world patients with mCSPC, with high rates of deep PSA response despite frequent AEs. These findings support the feasibility of triplet therapy in routine practice. Given the substantial toxicity burden, careful patient selection and proactive AE management remain important.

PMID:
42424546
Bibliographic data and abstract were imported from PubMed on 10 Jul 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.