Assessing the efficacy and safety of a novel targeted therapy in patients with metastatic hormone-sensitive prostate cancer (mHSPC) with PTEN loss

Overview

Prostate cancer is a common cancer in men, with standard treatment based on androgen deprivation therapy (ADT) combined with hormonal agents. However, treatment may be less effective in patients with metastatic hormone-sensitive prostate cancer (mHSPC) who have PTEN gene loss, a factor associated with rapid disease progression and poor prognosis. This global study aims to evaluate the efficacy and safety of a novel targeted therapy in combination with abiraterone (plus prednisone/prednisolone) on a background of ADT, with the goal of improving disease control and prolonging survival.

Inclusion Criteria

Men aged ≥18 years
Metastatic hormone-sensitive prostate cancer (mHSPC) with documented PTEN loss
Currently receiving ADT with a GnRH analog (with or without a first-generation androgen receptor antagonist such as bicalutamide), or an LHRH antagonist, or bilateral orchiectomy

Exclusion Criteria

History of radical prostatectomy or definitive radiotherapy for curative intent
Brain metastases or spinal cord compression (unless the spinal cord compression is asymptomatic, has been treated and is stable, and has not required steroid medication for at least 4 weeks before the start of study treatment).
Severe or uncontrolled systemic disease (e.g. hepatitis B, hepatitis C, HIV, …)

PI

Specialist Level I, MD Nguyễn Thị Phi Yến – Oncology Center, Vinmec Times City Internation Hospital

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