Study of Apalutamide Plus Androgen Deprivation Therapy with or without Local Treatment in Men with Metastatic Hormone-Sensitive Prostate Cancer

What this Trial Is About

Researchers are evaluating treatment options for men with metastatic hormone-sensitive prostate cancer. This Italian multicenter study aims to compare the effectiveness of apalutamide combined with androgen deprivation therapy ADT followed by local treatment versus apalutamide plus ADT alone. The goal is to see if adding radiotherapy or radical prostatectomy after 6 months improves the time patients live without cancer progression seen on scans. Participants will all start with apalutamide tablets taken daily along with ADT. After 6 months, they will be randomly assigned to either continue medical therapy alone or receive additional local treatment chosen by their doctor, including radiotherapy or surgery. Radiotherapy involves specific doses over several weeks, and surgery is planned to occur about 6 months after starting apalutamide. During the study, patients will be monitored for cancer progression using scans and clinical assessments up to 48 months. Researchers will also evaluate tumor shrinkage, side effects, time until cancer becomes resistant to hormones, survival outcomes, and quality of life using questionnaires. Participants will be followed closely with regular visits and tests to record these outcomes and ensure safety throughout the study period.

Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment