Phase 3 Trial of the ArteraAI Prostate Test Begins Enrollment
The first patient has been enrolled in the PROSTATE-IQ trial of ArteraAI, a multimodal artificial intelligence biomarker test.
Two prostate cancer cells in the final stage of cell division: ©PRB ARTS - stock.adobe.com
The phase 3 PROSTATE-IQ trial (NCT06274047) evaluating the ArteraAI Prostate Test and its ability to accurately identify patients who can safely reduce or avoid treatment with hormone therapy has enrolled its first patient with prostate cancer recurrence after prostatectomy.1
ArteraAI is a multimodal artificial intelligence biomarker test that works by utilizing digital biopsy images from patients, as well as clinical data that can help predict which patients may benefit from a particular therapy and whether or not they may benefit.1 ArteraAI has already been validated in phase 3 randomized trials.
This parallel, randomized study leverages the ArteraAI Prostate Test to personalize treatment by assessing metastasis risk and identifying patients who may reduce or avoid hormone therapy. The trial aims to improve quality of life for patients with low-risk prostate cancer with biochemical recurrence post-prostatectomy by minimizing androgen deprivation therapy (ADT) adverse events.
“We are excited to partner with some of the world’s leading institutions on this transformational clinical trial, one that can radically improve not only patient outcomes but the quality of life for men with prostate cancer,” said Tim Showalter, MD, Chief Medical Officer of Artera, in a news release from the company.1 “There has been tremendous eagerness from the medical community to start adopting risk stratification tools in this fashion with this patient population—those with biochemical recurrence after prostatectomy. We’re excited to see our test being used to help determine the optimal treatment therapy, reduce unnecessary side effects, and increase confidence in treatment planning.”
Approximately 120 patients with histologically confirmed prostate cancer are planned to be enrolled at up to 11 clinical trial sites across the US in the PROSTATE-IQ trial.2
The study plans to stratify patients into 2 groups. The first group, those who are low-risk, will be randomly assigned to 6 months of ADT or apalutamide monotherapy. The second group, those who are high-risk, will be randomly assigned to 24 months of ADT or 6 months of ADT with apalutamide.
Enrollment in the study is for patients aged 18 years or older who have a prostate-specific antigen level of 0.1 ng/mL or higher following radical prostatectomy, an ECOG performance status of 2 or lower, and adequate organ function. Patients are required to also be a candidate for salvage radiation and ADT treatment.
The primary end point of the study evaluates quality of life via questionnaires and wearables, while secondary end points include toxicity, activity, sleep, cognitive function, mental health, body composition, and cancer control.
The University of Texas MD Anderson Cancer Center is the primary site of the trial, but up to 10 additional sites are actively enrolling patients. Further, the primary completion date of the trial is set for June 30, 2027, and the estimated study completion date is June 2029.
