(UroToday.com) The 2026 ASCO GU Annual Symposium was host to a prostate cancer poster session. Dr. Amit Bahl presented real-world data from the UK-based RECOMMEND study evaluating the impact of age, number of chemotherapy cycles, and presence of visceral metastases on PSA response in metastatic hormone-sensitive prostate cancer (mHSPC) patients receiving triplet therapy (ADT + darolutamide + docetaxel).
Darolutamide in combination with ADT and docetaxel was approved by NICE in the UK following the ARASENS trial, which demonstrated improved overall survival with triplet therapy compared with ADT plus docetaxel.1 However, real-world data evaluating the impact of patient age, chemotherapy exposure, and visceral metastases on PSA response in routine practice remain limited. The RECOmMENd study was designed as a prospective real-world evaluation of clinical outcomes among patients with mHSPC treated with triplet therapy in the UK.
A total of 315 patients were enrolled from 21 UK centers over a 20-month period beginning in November 2022, with a data cut-off of September 22, 2025. The median age was 67 years (range 38–84). ECOG performance status was 0 in 63% and 1 in 37% of patients. The majority of patients had Gleason score ≥8 disease (70%), and 92% presented with de novo metastatic disease. Sites of metastases included bone (87.6%), lymph nodes (62.5%), lung (13%), and liver (3%).
Analysis of the PSA dynamics demonstrated substantial and sustained biochemical responses. The median PSA at diagnosis was 136 ng/mL. At the start of darolutamide, the median PSA had declined to 11.1 ng/mL, and at completion of docetaxel it was 0.4 ng/mL. After 6 months of darolutamide therapy (6MFU), the median PSA was 0.18 ng/mL (range 0–523), and after 12 months (12MFU), the median PSA further declined to 0.07 ng/mL (range 0–86). The median time from initiation of ADT to initiation of darolutamide was 8 weeks (IQR 4.9–10.6), consistent with UK NICE guidance.
Among 298 evaluable patients at 6 months, 94% achieved at least a 50% PSA decline (PSA50), and 72% achieved at least a 90% decline (PSA90). At 12 months, among 252 evaluable patients, 92% achieved PSA50 and 79% achieved PSA90, demonstrating sustained deep PSA responses over time.
The proportion of patients achieving PSA ≤0.2 ng/mL increased progressively during treatment. While none had PSA ≤0.2 ng/mL at diagnosis, 3.5% (11/312) had achieved this threshold at the start of darolutamide, increasing to 55% (166/298) at 6 months and 64.3% (151/252) at 12 months.
Importantly, subgroup analyses demonstrated consistent PSA responses irrespective of age (<75 vs ≥75 years), number of cycles of docetaxel received (≤4 vs >4), or the presence versus absence of visceral metastases (lung or liver). At 12 months, the percentage of patients achieving PSA ≤0.2 ng/mL did not significantly differ by age group, chemotherapy exposure, or visceral metastatic status. A similar pattern was observed at 6 months.
Collectively, these real-world UK data from the RECOmMENd study demonstrate robust and sustained PSA responses with ADT plus darolutamide plus docetaxel in mHSPC, consistent with the efficacy observed in the ARASENS trial. Notably, depth of PSA response appears independent of age, chemotherapy intensity, and visceral metastatic involvement, supporting the generalizability of triplet therapy across clinically relevant subgroups in routine practice.
Presented by: Amit Bahl, MBBS, FRCR, Consultant Clinical Oncologist, Department of Clinical Oncology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom
Written by: Rashid K. Sayyid, MD, MSc, Assistant Professor, Urologic Oncologist, Department of Urology at The University of Arizona and Banner University Medical Center, Tucson, AZ – @rksayyid on X during the 2026 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 26 – Sat, Feb 28, 2026.
References:
- Smith MR, Hussain M, Saad F, et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142.