ADT + ARPIs for Prostate Cancer

This trial explores whether using androgen deprivation therapy (ADT) only when necessary can reduce side effects for men with metastatic hormone-sensitive prostate cancer. Participants will stop and restart ADT based on their testosterone levels while consistently taking an androgen receptor pathway inhibitor (ARPI) for safety. The trial will assess how this method affects quality of life and monitor for any return of cancer symptoms. Men who have been on continuous ADT and ARPI for at least 18 months and have stable PSA levels might be suitable candidates for this study.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in prostate cancer care.

Research has shown that androgen receptor pathway inhibitors (ARPIs), used for advanced prostate cancer, are generally safe but may cause some side effects. A review of studies found that patients taking only ARPIs experienced more serious side effects than those on traditional hormone therapy. However, the FDA has approved ARPIs for certain stages of advanced prostate cancer, indicating they have passed safety checks for those conditions.

Researchers are excited about the combination of continuous Androgen Receptor Pathway Inhibitors (ARPIs) with intermittent Androgen Deprivation Therapy (ADT) for prostate cancer because it introduces a flexible treatment approach. Unlike standard treatments, which typically involve continuous ADT, this method adjusts ADT based on testosterone levels, potentially minimizing side effects while maintaining effectiveness. This strategy aims to improve patients' quality of life by reducing the burden of constant hormone therapy, offering a new way to manage prostate cancer more precisely.

Research has shown that combining androgen receptor pathway inhibitors (ARPIs) with hormone therapy, also known as androgen deprivation therapy (ADT), can extend the lives of men with prostate cancer. In this trial, participants will receive continuous ARPI with intermittent ADT based on supra-castrate testosterone levels. Studies have found that this combination can extend life by 18-24 months compared to hormone therapy alone. Furthermore, a 90% drop in prostate-specific antigen (PSA) levels within six months of starting ARPIs strongly indicates effective treatment. In such cases, patients often experience better control over cancer progression. Initiating treatment with ARPIs also improves survival outcomes, underscoring their importance in treating hormone-responsive, metastatic prostate cancer.⁶⁷⁸⁹¹⁰