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

Background

Managing locally advanced prostate cancer (PCa) and oligometastatic prostate cancer (OMPCa) is challenging. Because PCa can vary greatly from patient to patient, we need personalized treatment approaches. This study aims to see if using genomic markers to guide treatment can improve patient outcomes in a Chinese population.

Methods

This study is a phase II clinical trial involving 40 patients. We will analyze genetic data from prostate cancer tissue samples taken during biopsies. Based on these results, patients will be grouped and receive tailored treatments, including combinations of specific drugs. The main goal is to see how many patients achieve a complete pathological response, while secondary goals include overall survival rates and safety of the treatments.

Discussion

SEGNO is the first trial of its kind aimed at providing strong evidence for using genomic-guided therapy in treating locally advanced and oligometastatic prostate cancer.

Measurable Outcomes

We will define clear goals for safety and effectiveness of the genomic-guided therapy. This will help clinics and patients understand the potential benefits of this approach.

AI Tools for Clinical Needs

We will select AI solutions that are specifically designed to meet the needs of this clinical trial, ensuring that we can analyze data effectively and improve patient care.

Implementation Steps

We will start with a pilot project to test our approach, using AI tools to track results and assess the real-world impact of the genomic-guided therapy.