[225Ac]Ac-FL-020 for Prostate Cancer

(ProTACT Trial)

This trial tests a new treatment called [225Ac]Ac-FL-020 for prostate cancer that has spread and is resistant to standard hormone therapy. The main goals are to assess the treatment's safety, effectiveness, and how the body processes it. Suitable participants have prostate cancer unresponsive to castration treatment, evidence of disease spreading, and have undergone previous treatments like hormone therapy or taxane chemotherapy. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any systemic anti-cancer therapy within 6 weeks before starting the trial, except for stable bisphosphonate or denosumab regimens.

A previous study found the treatment [225Ac]Ac-FL-020 to be relatively safe for patients with prostate cancer. The most common side effect, dry mouth, affected about 77.1% of patients, with only 3% experiencing it severely. Other side effects were mild and manageable.

Researchers are excited about [225Ac]Ac-FL-020 for prostate cancer because it introduces a novel approach by using targeted alpha therapy. Unlike standard treatments like hormone therapy, chemotherapy, or radiation, this drug uses actinium-225, a radioactive substance, to deliver targeted radiation directly to cancer cells. This method aims to maximize the destruction of cancer cells while minimizing damage to surrounding healthy tissues. Additionally, its administration includes dosimetry with [111In]In-FL-020, which helps optimize the treatment plan by accurately measuring radiation doses received by the tumor. This precision and targeted action bring hope for increased effectiveness and reduced side effects compared to traditional therapies.

Research has shown that treatments like \[225Ac\]Ac-FL-020, including \[225Ac\]Ac-PSMA, have been very effective for prostate cancer. Specifically, a review of six studies involving 201 patients found that \[225Ac\]Ac-PSMA-617 effectively treated advanced prostate cancer unresponsive to hormone therapy. In this trial, researchers are studying \[225Ac\]Ac-FL-020, and some patients in early studies have shown signs of the treatment fighting cancer cells. The FDA has granted \[225Ac\]Ac-FL-020 fast-track status, indicating significant promise. While more research is needed, these early results suggest \[225Ac\]Ac-FL-020 could be a valuable option for those with advanced prostate cancer.¹²⁵⁶⁷