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An Orthotopic Murine Model of Human Prostate Cancer Metastasis
Published on: September 18, 2013
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Prostate-Specific Antigen Response at Six Months Predicts Progression in Metastatic Hormone-Sensitive Prostate Cancer
Christian Andrés Martínez Osorio1,2, Raquel Sopeña Sutil3, Antoni Vilaseca Cabo4
1Instituto Valenciano de Oncología, Valencia, Spain.
The Prostate
|September 4, 2025
Summary
Prostate-specific antigen (PSA) response at six months in metastatic hormone-sensitive prostate cancer patients treated with apalutamide and androgen deprivation therapy (ADT) predicts longer radiographic progression-free survival. This real-world evidence confirms PSA levels as a key prognostic biomarker.
Area of Science:
- Oncology
- Prostate Cancer Research
- Clinical Biomarkers
Background:
- Prostate-specific antigen (PSA) response to apalutamide plus androgen deprivation therapy (ADT) is linked to prognosis in metastatic hormone-sensitive prostate cancer (mHSPC).
- Clinical trial data suggest PSA levels at 6 months are critical for predicting radiographic progression-free survival (rPFS) and overall survival (OS).
- Real-world evidence (RWE) is necessary to validate these findings in diverse patient populations.
Purpose of the Study:
- To evaluate the association between PSA response at 6 months and rPFS at 24 and 36 months in mHSPC patients treated with apalutamide plus ADT.
- To identify independent predictors of progression using univariate and multivariate Cox regression analyses.
- To determine factors predicting achievement of a complete PSA response.
Main Methods:
- Retrospective, multicenter study of 812 mHSPC patients treated with apalutamide plus ADT across 18 Spanish centers (May 2018 - January 2025).
- Patients stratified by PSA level at 6 months: Complete Response (CR; ≤ 0.2 ng/mL) or Incomplete Response (IR; > 0.2 ng/mL).
- Statistical analyses included Cox regression to assess predictors of rPFS and CR.
Main Results:
- 65% of patients achieved a CR at 6 months.
- CR was associated with significantly higher rPFS at 24 months (94% vs. 73%) and 36 months (81% vs. 60%) compared to IR (p < 0.0001).
- CR (HR: 0.38) and low-volume disease (HR: 0.41) were independent predictors of rPFS; baseline PSA, disease volume, and PET imaging predicted CR.
Conclusions:
- PSA response at 6 months is a strong predictor of disease progression in mHSPC patients treated with apalutamide plus ADT in a real-world setting.
- This finding supports the utility of PSA response as a dynamic prognostic biomarker.
- Early identification of non-responders can potentially guide treatment strategies and improve patient outcomes.
