Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial.

ABSTRACT:

Background

The management of locally advanced prostate cancer (PCa) and oligometastatic prostate cancer (OMPCa) remains a clinical challenge. The heterogeneous nature of PCa prompts a need for precision treatment. This study aims to verify whether genomic biomarker-guided neoadjuvant therapy for locally advanced PCa and OMPCa can result in an improvement in the pathological responses and survival outcomes in a Chinese population.

Methods

In this open-label prospective phase II umbrella clinical trial, 40 patients will be enrolled. Next-generation sequencing data analysis of PCa tissues from the diagnostic needle biopsies will be performed. The genomically evaluable patients will be divided into 4 groups on the basis of genomic testing results, and receive 6 cycles of patient

SUBMITTER: Huang H 

PROVIDER: S-EPMC11895121 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature