ASCO GU 2025: Treatment Patterns in Prostate Cancer Patients Who Received Darolutamide in the ARAMIS Trial in Spain: PARASEC Study

(UroToday.com) The 2025 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Javier Puente discussing the PARASEC study assessing treatment patterns in prostate cancer patients who received darolutamide in the ARAMIS trial in Spain. Darolutamide, enzalutamide or apalutamide have demonstrated to prolong overall survival in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Despite their effectiveness, almost all patients progress to mCRPC. Darolutamide showed significantly prolonged metastasis-free survival and overall survival compared with placebo in patients with nmCRPC in ARAMIS phase III trial.^1,2 In the last few years, several new options for treatment of advanced prostate cancer have shown a survival benefit. However, there is a lack of data about treatment patterns of patients that progress after receiving darolutamide in nmCRPC in the real-world setting with new life-prolonging treatments available.

 This is a retrospective, observational, multicenter, longitudinal follow-up study to describe the treatment patterns received by the Spanish patients who received darolutamide in the ARAMIS study, according to standard clinical practice in Spain. This study involved Urology and Oncology Departments of 18 selected hospitals.

There were 85 patients included in the study, with a median age of 76 years, and of which 49 patients (58%) progressed to mCRPC. Of these, 35 (71%) received treatment for mCRPC, with a median number of lines post-progression of 2 (range 1-5):
Abiraterone (22/35 [63%]) and docetaxel (10/35 [29%]) were the most commonly used drugs in the first line, docetaxel (12/21 [57%]) and cabazitaxel (12/21 [19%]) in the second line, and cabazitaxel (4/12 [33%]) and docetaxel (3/12/21 [25%]) in the third line:

Eleven patients received palliative radiotherapy (11/35 [31%]) and 7 (7/35 [20%]) received osteoclast targeted therapy (n = 5 zoledronic acid; n = 2 denosumab) after darolutamide:
The following highlights mCRPC treatment line sequence after darolutamide:
Dr. Puente concluded his presentation discussing the PARASEC study assessing treatment patterns in prostate cancer patients who received darolutamide in the ARAMIS trial in Spain with the following take-home points:

• The results show that 29% of patients who progressed to mCRPC do not receive treatment after darolutamide and of those receiving treatment, 63% receive abiraterone, which appears not to be in line with current European guidelines
• Only one-fifth of patients receive osteoclast targeted therapy, which is clearly insufficient
• The variability in the duration of treatments and sequences suggests a lack of consensus in Spanish clinical practice
• It is critical to explore more standardized strategies to maximize treatment effectiveness in these patients

Presented by: Javier Puente, MD, PhD, Medical Oncology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025. 

Related content: PARASEC Study Reveals Real-World Treatment Patterns After Darolutamide in ARAMIS Trial - Javier Puente

References:

1. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246.
2. Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049.