Prostate cancer remains the most common cancer and the second leading cause of death among males in the United States. Researchers at UCSF are delving into the genetic underpinnings of prostate cancer to uncover additional gene mutations that may influence the disease's aggressiveness and response to treatment. This study targets adult males aged 18 and older who have been diagnosed with prostate cancer, possess specific gene mutations of interest, or have experienced complete cancer elimination or stable disease over an extended period.
Participants undergo a comprehensive screening process, including medical record reviews and genetic testing. The study emphasizes the importance of understanding how gene mutations affect cancer progression and treatment response, without requiring participants to visit the NIH for study purposes. However, those who do visit NIH for other studies will have their data and test results collected for this research. Participants may also provide blood, urine, and tumor samples for genetic analysis, with follow-ups conducted every six months to monitor health status.
The research also explores the efficacy of combining darolutamide, a new generation androgen receptor inhibitor (ARI), with androgen deprivation therapy (ADT) in prolonging the time participants live without their cancer worsening. This approach is compared against a placebo and ADT over a 24-month period. Advanced imaging techniques, such as PSMA PET/CT scans, are employed to detect prostate cancer lesions not visible through conventional imaging methods, offering a more sensitive means of monitoring cancer spread.
Participants are randomly assigned to one of two treatment groups, receiving either darolutamide plus ADT or placebo plus ADT. The study encompasses a screening phase, a treatment phase, and a follow-up phase, with the treatment duration set at 24 months unless the cancer progresses, participants experience medical issues, or they choose to leave the study. Throughout the study, participants' health is closely monitored through physical examinations, PSA and testosterone level measurements, electrocardiograms (ECG), and vital sign checks, alongside regular assessments of cancer status using PSMA PET/CT, CT, MRI, and bone scans.
This clinical trial represents a significant step forward in understanding and treating prostate cancer, particularly for men at high risk of biochemical recurrence, by leveraging genetic insights and advanced therapeutic strategies to improve patient outcomes.
