Hormone Therapy for Prostate Cancer

This trial tests the effectiveness of hormone therapy on a prostate cancer marker before and after surgery. Participants will receive one of four hormone treatments—Degarelix, Leuprolide, Relugolix, or Triptorelin—to shrink the cancer before prostate removal. The study will monitor any new or worsening symptoms over time. Men with prostate cancer who haven't undergone prior radiation therapy and meet specific health criteria may qualify for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Previous studies have shown that degarelix is effective and generally well-tolerated for over three years in patients with prostate cancer. However, some patients experienced more side effects compared to other treatments, with about 60% reporting them.

Leuprolide is usually well-tolerated, but hot flashes commonly affect nearly half of the patients. Some also reported tiredness and higher blood pressure.

Relugolix has demonstrated a good safety record in real-world studies. Common side effects include hot flashes, tiredness, and muscle pain. Serious side effects were very rare, occurring in less than 1% of patients.

Triptorelin effectively lowers testosterone levels, aiding in prostate cancer treatment. It is generally well-tolerated, though some patients reported mood changes and depression. Regular check-ups are recommended, especially for those with a history of depression.

Researchers are excited about these treatments for prostate cancer because they offer a variety of administration methods and potentially improved patient experiences. Unlike standard hormone therapies, which often require frequent injections, Relugolix is an oral pill taken daily, providing more convenience and possibly fewer side effects related to injection sites. Degarelix, administered under the skin, offers a different approach from the traditional intramuscular injections of Leuprolide and Triptorelin, and it can rapidly reduce testosterone levels, which is crucial in managing prostate cancer. Additionally, the use of 18F-flotufolastat PET scans aims to enhance treatment monitoring and precision, potentially leading to better outcomes.

In this trial, participants will receive one of four hormone treatments: Degarelix, Leuprolide, Relugolix, or Triptorelin, as part of neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy. Research has shown that these hormone treatments effectively manage prostate cancer by lowering testosterone levels, which is crucial for slowing cancer growth. Specifically, Degarelix kept testosterone levels low for nearly a year in 97% of patients. Leuprolide also showed strong results, with over 90% of patients reaching low testosterone levels. Relugolix achieved even higher success rates, lowering testosterone in over 98% of cases. Triptorelin effectively reduced testosterone levels to the desired range in more than 90% of patients within six months. These treatments are well-researched and target testosterone, a key factor in prostate cancer.⁴⁶⁷⁸⁹