What question did this study set out to answer?

The aim is to evaluate the real-world outcomes of apalutamide therapy in mHSPC patients based on age, dose adjustments, and PSA levels.

May 30, 2026

Real-World outcome of apalutamide therapy in mHSPC patients depending on age, dose reduction, and PSA decline: Data from the German AmPel trial.

Key Points

The aim is to evaluate the real-world outcomes of apalutamide therapy in mHSPC patients based on age, dose adjustments, and PSA levels.
Data collected from 127 mHSPC patients in a multicenter trial since November 2021.
Outcomes including PSA response (low and ultra-low levels), side effects, and dose reductions were tracked.
Median follow-up period was 14 months with approval from an ethics committee.
PSA levels dropped by 98.5% after 3 months and 99.5% after 12 months.
Significant progression-free survival (PFS) benefits for achieving UL-1 (HR 0.28) and UL-2 (HR 0.06) PSA levels.
Overall, 77.2% of patients continued treatment after 12 months with good tolerability.

Abstract

e17094 Background: Data from the Titan Trial (apalutamide + ADT) showed a benefit for mHSPC patients who achieved low ( 75 years, p = 0.46) nor in case of dose reduction (15%) of APA (p = 0.7). After 12 months, 32.6% of pat reached a UL-2 PSA and nearly the same number (31.6%) reached a UL-1 PSA. There was a significant PFS advantage for UL-1 PSA (HR 0.28) and UL-2 PSA (HR 0.06). In the overall cohort, PFS has not been reached yet. Currently, 77.2% are still receiving APA. In 22.8% treatment was discontinued after a median of 8 months: in 9.4% due to progression. Overall, 7 pat died – 2 (1.6%) due to PCA. Conclusions: Our Real World Data show that APA therapy is highly effective in mHSPC and achieving UL-PSA quickly and sustainably (64.2% after 12 months) as well as PSA decrease of > 95% (91.6% after 12 months) - associated with significantly improved PFS in an unselected patient population and good tolerability in daily practice.

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