Study Background

This Phase 2 clinical trial evaluates the safety and efficacy of combining local ablation (focal therapy) with androgen deprivation therapy (ADT) in patients with prostate cancer. While each treatment has been used separately, combining them may enhance tumor suppression. Prostate cancer commonly affects older men, and treatment choices significantly impact their quality of life.

Trial Design

This Phase 2 study, currently recruiting, began on May 5, 2025. The primary endpoints are safety profile and post-treatment PSA reduction rate, while secondary endpoints include histological response and changes in quality of life. The target population is men diagnosed with progressive prostate cancer, focusing on those with resistance to existing ADT or limited options for local treatment.

Differentiation from Current Treatment Landscape

Current standard treatment for prostate cancer involves a combination of systemic ADT, radiation therapy, and surgical prostatectomy. Local ablation offers a minimally invasive option with fewer side effects, but its long-term efficacy is limited when used alone. Combining both treatments is expected to directly eliminate tumor sites and suppress the systemic hormonal environment, potentially reducing the risk of recurrence.

Expected Outcomes and Impact

If successful, the combination of local ablation and ADT will provide a new treatment option for prostate cancer, potentially minimizing side effects while maintaining or improving efficacy compared to existing treatments. It may also provide a basis for expanding similar combination strategies to other hormone-dependent cancers.