Efficacy and safety of darolutamide (DARO) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and a prostate-specific antigen doubling time (PSADT) > and <= 6 months.

K. Schlack, M. R. Smith, N. D. Shore, T. L. J. Tammela, A. Ulys, E. Vjaters, S. Polyakov, M. Jievaltas, M. Luz, B. Alekseev, I. Kuss, M. -A. Le Berre, A. Snapir, T. Sarapohja, K. Fizazi

Research output: Contribution to journalMeeting Abstractpeer-review


Background: In the phase 3 ARAMIS trial, darolutamide (DARO) significantly improved metastasis-free survival (MFS) in patients with nmCRPC and PSADT ≤10 months. Patients in ARAMIS were stratified by PSADT ≤6 months and >6 months. Here we present the efficacy and safety of DARO in ARAMIS participants with a PSADT >6 months. Materials: The double-blind, placebo-controlled phase III ARAMIS trial randomized 1509 patients with nmCRPC and PSADT ≤10 months in a 2:1 ratio to receive DARO 600 mg twice-daily (n=955) or placebo (PBO; n=554), while continuing androgen deprivation therapy. Patients were stratified by PSADT (≤6 months or >6 months) to assess the effect on efficacy and safety. Results: In the overall population, median (range) baseline PSADT was 4.4 (0.7-11.0) months in the DARO arm and 4.7 (0.7-13.0) months in the PBO arm. Around 30% of patients in each arm had PSADT >6 months. In the subgroup of patients with PSADT >6 months, the risk of metastasis or death was reduced by 62% with DARO as compared with PBO (hazard ratio [HR] 0.38; 95% confidence interval [CI] 0.26-0.55), in line with both the overall population (HR 0.41; 95% CI 0.34-0.50) and with patients with PSADT ≤6 months (HR 0.41; 95% CI 0.33-0.52). Median (95% CI) MFS was not estimable (40.5 months-not estimable) and 34.3 months (30.8 months-not estimable) for patients with PSADT >6 months and ≤6 months, respectively. At interim analysis, HR for improved OS vs PBO showed a similar trend. The safety profile of DARO, including AEs of interest, for patients with PSADT >6 months was consistent with that of the overall study population. Conclusions: The MFS benefit and safety of DARO is similar in the subset of patients with PSADT >6 months and the overall ARAMIS study population.
Original languageEnglish
Article numberMeeting Abstract: 147
Pages (from-to)223-223
JournalOncology Research and Treatment
Issue numberSUPPL 4
Publication statusPublished - Oct 2020
Externally publishedYes

Field of Science

  • 3.2 Clinical medicine
  • 3.1 Basic medicine

Publication Type

  • 3.3. Publications in conference proceedings indexed in Web of Science and/or Scopus database

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