NCT07352748

Exploiting Heterogeneity in Hormone Therapy Response to Reveal Early Determinants of Drug Resistance in Advanced PCa

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to study intra-patient tumor and TME heterogeneity after initiation of hormonal therapy (ADT +- ARSI), while the patient is responding to treatment, to understand the drivers of hormonal therapy resistance and identify potential novel therapeutic targets in metastatic prostate cancer patients. The main question it aims to answer if intra-tumor adaptive mechanisms including expression of immune checkpoint proteins and changes in the tumor immune infiltrate are related to the induction of a senescent phenotype in response to hormonal therapy. Participants will asked to provide an FFPE and/or fresh biopsy sample from the primary tumor or a metastatic site at baseline (before starting hormonal therapy) and during the course of hormonal therapy. Additionally, a maximum of 2 blood tubes (10ml) will be collected each time.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	biopsy	A fresh tumor biopsies and an FFPE block will be taken at baseline (alternatively, as a basal biopsy could be used archival FFPE tumor material left over from surgical procedures or previous biopsies if available and if a fresh biopsy at baseline is not feasible or safe; in case of availability of frozen and FFPE archival blocks, 1 frozen block and 1 FFPE block will be used for the analyses) and after 2-4 weeks of hormonal treatment with ADT and/or AR inhibitors. Biopsies will be performed guided by ultrasound or CT, depending on location. From each Fresh biopsy, 2 core biopsies will be collected, 1 will be processed into an FFPE block, and the second will be processed according to freezing procedures.
PROCEDURE	Prostate biopsy	Fresh and FFPE block tumor biopsies at baseline

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-09-11
• Completion: 2026-10-17
• First posted: 2026-01-20
• Last updated: 2026-01-28

Locations

1 site across 1 country: Italy