Overall survival (OS) remains the gold standard in oncology trials, but waiting for long-term OS data can delay access to life‑prolonging therapies. Radiographic progression‑free survival (rPFS) has been increasingly used as a meaningful imaging-based primary endpoint in clinical trials for advanced prostate cancer. Assessing the relationship between intermediate endpoints and OS can help predict long-term clinical outcomes earlier, accelerating decision-making and the incorporation of effective drugs into clinical practice.
To understand whether rPFS can serve as a valid surrogate for OS in first-line androgen receptor pathway inhibitor (ARPi)-naïve metastatic castration-resistant prostate cancer (mCRPC), the Value & Evidence team at EVERSANA (Imtiaz Samjoo, Stefanie Paganelli, Anja Haltner and Di Wang) conducted a systematic literature review and trial-level correlation analysis across 11 randomized controlled trials (RCTs) using methodology recommended by the Institute for Quality and Efficiency in Health Care (IQWiG), the health technology assessment (HTA) body in Germany.
The results demonstrated medium to high correlation between rPFS and OS. When considered alongside other criteria defined by IQWiG, our findings support rPFS as a valid surrogate endpoint for OS in first-line ARPi-naïve mCRPC.
Why it matters: Validating rPFS as a surrogate endpoint can accelerate clinical development and regulatory pathways, enabling patients to access effective therapies sooner while maintaining high standards of evidence.
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Author
As an Associate Manager on the Value & Evidence team at EVERSANA, Stefanie contributes to evidence synthesis projects that support global Health Economics and Outcomes Research (HEOR) initiatives. Since joining EVERSANA in 2021, Stefanie…