Hormone Therapy + Radiation for Prostate Cancer

This trial evaluates the effectiveness of different prostate cancer treatments based on the Decipher score, a specific genetic test. The study consists of two parts: one for patients at higher risk of cancer spreading and another for those at lower risk. Patients with a higher score will test whether adding darolutamide (a hormone therapy) to hormone therapy and radiation helps prevent cancer recurrence. Those with a lower score will determine if radiation alone is as effective as the usual combined treatment. Men with prostate cancer who haven't undergone major surgery or radiation to the prostate and meet certain medical criteria may qualify. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial requires that you stop taking any testosterone replacement therapy and 5-alpha-reductase inhibitors at least 30 days before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Research shows that the treatments in this trial—radiation therapy, darolutamide, and androgen deprivation therapy (ADT)—are generally well-tolerated by patients.

Radiation therapy is safe and effective for prostate cancer. It targets cancer cells while minimizing harm to nearby tissues, resulting in fewer side effects for many patients.

Darolutamide has shown promising results in other studies. It improved survival rates and was generally well-tolerated, with only a small number of patients needing to lower their dose due to side effects.

ADT helps fight cancer by lowering testosterone levels. It is widely used and has a known safety record. Some patients may experience side effects like hot flashes, but overall, it is considered safe.

Researchers are excited about these prostate cancer treatments because they combine hormone therapy with radiation, potentially enhancing effectiveness. While standard treatments often involve just one approach, like radiation alone or hormone therapy, this study explores combining them for a one-two punch against cancer cells. The inclusion of darolutamide, a newer androgen receptor inhibitor, is particularly promising because it may provide a more targeted approach in blocking cancer cell growth compared to older therapies. By examining different combinations and delivery methods, these treatments could offer a more comprehensive way to manage prostate cancer with potentially fewer side effects.

Research has shown that radiation therapy, one of the treatments in this trial, effectively treats prostate cancer that hasn't spread. Studies indicate it can control the disease and prevent further spread. In this trial, some participants will receive radiation therapy alone, while others will receive it with hormone therapy. Specifically, using darolutamide with androgen deprivation therapy (ADT), which lowers male hormones, has greatly improved outcomes. One study demonstrated a 40% increase in the time patients live without cancer progression compared to standard treatments. Androgen deprivation therapy alone, another option in this trial, effectively reduces testosterone, helping to slow cancer growth. Together, these treatments offer promising results for prostate cancer patients.²⁶⁷⁸⁹