PSMA Imaging + Bicalutamide for Prostate Cancer

This trial explores how bicalutamide, a hormone therapy, affects the levels of a protein linked to prostate cancer. Researchers aim to determine if this drug alters protein levels in prostate cancer patients with low PSA, a marker used to track the disease, who are at higher risk of recurrence. Participants will be divided into two groups: one will undergo scans before and after taking the medication, while the other will have only a pre-treatment scan. Men diagnosed with prostate cancer within the last two years, who have low PSA levels and plan to undergo radiation therapy, might be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

If you are currently taking bicalutamide, you can continue if you started it up to 3 days before joining the trial. Otherwise, you need to stop taking it for at least 42 days before starting the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Research has shown that patients generally tolerate bicalutamide well. With over 2800 years of patient use, studies have found that few people discontinue treatment due to side effects. About 28.3% of patients reported serious side effects, which can be dangerous, but this rate is similar to other prostate cancer treatments.

Researchers are excited about PSMA Imaging combined with bicalutamide for prostate cancer because it offers a more precise way to assess the treatment's effectiveness. Unlike standard prostate cancer treatments that mainly focus on hormone therapy, this approach uses advanced PSMA PET/CT imaging to visualize cancer activity in real-time. This imaging method, employing 18F-rhPSMA-7.3 (F-18 flotufolastat), could potentially allow doctors to tailor treatments more effectively by monitoring how the cancer responds after just two weeks. With this enhanced ability to track the disease, patients may receive more personalized and timely interventions.

Studies have shown that bicalutamide effectively slows prostate cancer growth by blocking male hormones that aid its development. Research indicates it is often used to manage prostate cancer, particularly in patients whose PSA levels rise after treatment. In this trial, participants will receive standard-of-care bicalutamide. Additionally, PSMA PET/CT imaging with flotufolastat F 18 has been approved for effectively detecting prostate cancer spots, even when traditional imaging methods fail. This imaging tool helps doctors see the cancer more clearly, which is crucial for planning treatment. Participants in this trial will undergo PSMA PET/CT imaging to assess its effectiveness alongside bicalutamide. Both treatments have shown promise in improving prostate cancer detection and management.⁶⁷⁸⁹¹⁰