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Prostate Cancer Treatment and Research / Prostate Cancer Diagnosis and Treatment · Journal article
Advances in Therapy · September 6, 2026
Well-designed and adequately powered for the question it asks.
This real-world Japanese cohort study of 1,306 and 11,737 patients with mCSPC demonstrates that ADT plus ARSIs (enzalutamide, apalutamide, abiraterone, or darolutamide ± docetaxel) achieve higher cumulative PSA-90 response rates (90.7–91.8% at 3 months) compared with ADT alone (63.2%) or ADT plus NSAAs (69.3%), with longer median time-to-PSA-progression and time-to-treatment-discontinuation. No significant differences were observed among ARSI-based treatments on PSA endpoints, though apalutamide showed shorter median treatment duration, likely reflecting real-world clinical decisions around tolerability and adverse events rather than pure efficacy.
Retrospective cohort study. Males with metastatic castration-sensitive prostate cancer in Japan. Cohort 1 (n=1,306) had PSA data available; cohort 2 (n=11,737) included all eligible patients from the database. Study period: May 2020 to April 2024.. Intervention: ADT plus androgen receptor signaling inhibitors (ARSIs: enzalutamide, apalutamide, abiraterone, or darolutamide ± docetaxel) as first-line therapy for mCSPC.. Compared with: ADT alone or ADT plus nonsteroidal antiandrogens (NSAAs). n = 1,306. Japan (Medical Data Vision database).
At 3 months, cumulative PSA-90 response: ADT alone 63.2%, ADT + NSAAs 69.3%, ADT + enzalutamide 91.8%, ADT + apalutamide 90.9%, ADT + abiraterone 90.7%, ADT + darolutamide + docetaxel 81.2% Median TTPP was longer for ARSI-based treatments versus ADT alone and ADT + NSAAs In cohort 2 (n=11,737), median TTD was longer for ARSI-based treatments versus ADT alone and ADT + NSAAs
Reasons for treatment discontinuation (adverse events, clinical progression, patient choice) not detailed by cohort.
For clinicians in Japan treating mCSPC, this real-world evidence supports preferential use of ADT plus ARSIs (enzalutamide, apalutamide, abiraterone) over ADT monotherapy or NSAAs based on superior early PSA-response rates and prolonged treatment duration. However, differences in treatment continuation among ARSI agents suggest individualizing choice based on tolerability and adverse-event profile rather than PSA efficacy alone.
Large real-world retrospective cohort with prospectively collected data, clear PSA endpoints, and adjusted analysis demonstrating consistent superiority of ARSI-based regimens over ADT monotherapy in mCSPC, though limited by surrogate endpoints and lack of hard clinical outcomes.
As stated by the source record.
Quoted from the source exactly as published.
For clinicians in Japan treating mCSPC, this real-world evidence supports preferential use of ADT plus ARSIs (enzalutamide, apalutamide, abiraterone) over ADT monotherapy or NSAAs based on superior early PSA-response rates and prolonged treatment duration. However, differences in treatment continuation among ARSI agents suggest individualizing choice based on tolerability and adverse-event profile rather than PSA efficacy alone.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
With recent approvals in Japan, identifying optimal first-line therapy for metastatic castration-sensitive prostate cancer (mCSPC) is critical. We evaluated real-world outcomes of androgen-deprivation therapy (ADT) plus androgen receptor signaling inhibitors (ARSIs) as first-line therapies using prostate-specific antigen (PSA) responses and treatment duration. This retrospective study used the Medical Data Vision database (May 2020–April 2024). The study population included males with mCSPC, with two cohorts: cohort 1 (with PSA data); cohort 2 (all eligible patients). Primary endpoint: cumulative incidence of ≥ 90% PSA reduction (PSA90) during the first-line period. Secondary endpoints: PSA50; PSA ≤ 0.2 ng/mL; time to PSA progression (TTPP); time-to-treatment discontinuation (TTD). Endpoints were estimated using the Kaplan–Meier method evaluated using the Cox proportional hazards model, adjusted for baseline characteristics. In cohort 1 ( n = 1306), cumulative PSA90 response rates were higher with ADT + ARSI ± docetaxel (ARSI-based treatments) than with ADT alone or ADT + nonsteroidal antiandrogens (NSAAs) (at 3 months: ADT alone, 63.2%; ADT + NSAAs, 69.3%; ADT + enzalutamide, 91.8%; ADT + apalutamide, 90.9%; ADT + abiraterone, 90.7%; ADT + darolutamide + docetaxel, 81.2%). Cumulative PSA50 and PSA ≤ 0.2 ng/mL response rates were consistent with PSA90 findings. Median TTPP was longer for ARSI-based treatments versus ADT alone and ADT + NSAA. No significant differences were observed among ARSI-based treatments across these PSA-related endpoints. In cohort 2 ( n = 11,737), the median TTD was longer for ARSI-based treatments versus ADT alone and ADT + NSAAs. Notably, ADT + apalutamide showed a shorter median TTD than other ARSI-based treatments. Compared with ADT alone or ADT + NSAA, ARSI-based treatments showed faster PSA declines and longer treatment durations. While ARSI-based treatments demonstrated similar PSA-lowering effects, differences in treatment continuation likely reflect real-world clinical management influenced by not only PSA response but also adverse events and patient characteristics.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.