NUBEQA® (darolutamide) Impact on Local Symptoms Evaluated in Men with Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

  • Post-hoc analysis of the Phase III ARAMIS trial showed NUBEQA® (darolutamide) was associated with delayed deterioration in patient quality of life (QoL) related to urinary and bowel symptoms in men with non-metastatic castration-resistant prostate cancer (nmCRPC)1

San Francisco, CA ( -- A posthoc analysis of the Phase III ARAMIS trial presented at the 2021 AUA Annual Meeting assessing NUBEQA® (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) reinforces the established clinical profile.1,2 NUBEQA is indicated in the U.S. for the treatment of men with nmCRPC.

Research presented at the meeting found that NUBEQA plus androgen deprivation therapy (ADT) prolonged time to first prostate cancer-related invasive procedures, an exploratory endpoint (HR=0.416; 95% CI, 0.279-0.620), and was associated with a reduction in locally invasive procedures versus ADT alone (4.7% versus 9.6%). In a posthoc analysis, NUBEQA plus ADT also delayed the time to deterioration in quality of life (QoL) in two of the six subscales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-PR25): urinary symptoms (25.8 versus 14.8 months; HR=0.64; 95% CI, 0.54-0.76) and bowel symptoms (18.4 versus 11.5 months; HR=0.78; 95% CI, 0.66-0.92) versus ADT alone.1

In the Phase III ARAMIS trial primary analysis, serious adverse reactions in ≥ 1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria.

“Local symptoms from the prostate and surrounding tissues can be very detrimental to patients’ QoL. The occurrence of local symptoms and invasive procedures is very important in initial nmCRPC treatment discussions between patients and physicians,” said Neal Shore, MD, FACS, Medical Director, CPI, Carolina Urologic Research Center. “The results on QoL and invasive procedures reinforce NUBEQA’s value in nmCRPC.”

Data from the Phase III ARAMIS Trial

Previously published results in 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months (n=955) with NUBEQA plus ADT, compared to 18.4 months (n=554) for placebo plus ADT (p<0.001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.2

The six subscales of the EORTC-QLQ-PR25 are urinary symptoms, bowel symptoms, hormone treatment-related symptoms, incontinence aid use, sexual activity and sexual functioning.

The proven tolerability of NUBEQA was supported by the three adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo): fatigue (16% versus 11%), pain in extremity (6% versus 3%), and rash (3% versus 1%). NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.2


  1. Shore N. et al. Impact of darolutamide on local symptoms in patients with nonmetastatic castration-resistant prostate cancer [abstract]. AUA 2021. Presentation PD34-10.
  2. NUBEQA® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, January 2021.

Source: "NUBEQA® (Darolutamide) Impact On Local Symptoms Evaluated In Men With Non-Metastatic Castration-Resistant Prostate Cancer (Nmcrpc)". 2021. Bayer2019tf.Q4web.Com.

Related Content:

Delayed Deterioration in Patient Quality of Life, the Impact of Darolutamide on Local Symptoms in the ARAMIS Trial – Neal Shore

AUA 2021: Impact of Darolutamide on Local Symptoms in Patients with Nonmetastatic Castration-Resistant Prostate Cancer