Trial Design and Objectives for Castration‑Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group

Rákkutatás · Prostate cancer

The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) recommends updated baseline patient assessment, outcome measures, and serial biologic profiling to guide clinical trial design in castration‑resistant prostate cancer (CRPC).

This special article reports updated recommendations from the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for clinical trials in castration‑resistant prostate cancer (CRPC). The authors advocate baseline patient assessment that includes tumor histology, detailed prior treatment history, and a disease subtype classification based on metastatic spread pattern. For trial outcomes, PCWG3 recommends time‑to‑event endpoints such as symptomatic skeletal events, time to first metastasis, and time to progression in non‑metastatic CRPC. The report also introduces mandatory serial biologic profiling using biopsies, blood‑based diagnostics, and imaging to identify resistance mechanisms and predictive biomarkers for prospective trials.

These updated guidelines aim to streamline CRPC clinical trial design by mandating comprehensive baseline data, mandatory evaluation of clinically relevant endpoints, and mandatory molecular profiling. Mandating these standards is expected to accelerate the development of effective treatments Mandating mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory(1)

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