Androgen Deprivation Therapy for Prostate Cancer

This trial tests how well a short course of the medication relugolix works with imaging to detect prostate cancer that might have spread, especially in high-risk cases. Relugolix reduces testosterone, which can help identify more cancer cells during special imaging scans (PSMA PET/CT). The trial divides participants into three groups, each receiving relugolix for different lengths of time before imaging and surgery. Men with high-risk prostate cancer, such as those with aggressive forms or high PSA levels, might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy within 2 weeks before joining, and you cannot be on androgen deprivation therapy or pelvic radiation. It's best to discuss your specific medications with the trial team.

Research has shown that relugolix is generally well-tolerated by patients. In a study on its use for prostate cancer, only 2.9% of patients experienced major heart problems, compared to 6.2% with leuprolide. This suggests relugolix might pose a lower risk of heart issues. Another study found no new safety concerns when relugolix was combined with radiotherapy. These findings offer some reassurance about the safety of relugolix, but ongoing trials will continue to monitor for any issues.¹²³⁴⁵

Researchers are excited about relugolix for prostate cancer because it offers a new approach to androgen deprivation therapy (ADT). Unlike traditional ADT options like leuprolide, which are administered via injections and can take weeks to lower testosterone levels, relugolix is an oral medication that can rapidly reduce testosterone levels in just a few days. This faster action could potentially lead to quicker symptom relief and may improve the timing and effectiveness of subsequent treatments, like surgery. Additionally, as a non-invasive oral treatment, relugolix offers a more convenient alternative for patients compared to injectable therapies.

Research has shown that relugolix effectively treats prostate cancer by lowering testosterone levels, which helps slow cancer cell growth. In clinical studies, over 98% of patients using relugolix achieved very low testosterone levels, crucial for controlling prostate cancer. It acts quickly and maintains these low levels in patients with both early-stage and advanced prostate cancer. This trial will test different durations of relugolix treatment, with participants receiving it for 5, 10, or 15 days. This treatment is promising because it targets hormones that promote cancer growth. Additionally, relugolix might improve the ability of imaging tests to detect smaller cancer areas in the body.³⁵⁶⁷⁸