Artera Announces 1st Patient Enrolled in PROSTATE-IQ Trial to Reduce Burden of Hormone Therapy in Men with Prostate Cancer Recurrence After Prostatectomy

Clinical trial aims to guide doctors in selecting the most effective treatments that minimize the impact on quality of life while improving patient outcomes

Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, today announced the first patient enrollment in PROSTATE-IQ, a Phase 3 clinical trial in men with prostate cancer recurrence after prostatectomy. The trial utilizes the ArteraAI Prostate Test to enable treatment personalization by determining cancer metastasis risk and identifying whether patients may be able to reduce or avoid hormone therapy.

The trial is being led by Karen Elizabeth Hoffman, M.D., Professor of Radiation Oncology, and Mays Radiation Oncology Center Medical Director at The University of Texas MD Anderson Cancer Center.

“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, M.D., Chief Medical Officer of Artera. “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.”

The current standard of care for these patients is radiation, oftentimes combined with a hormone therapy called androgen deprivation therapy (ADT). ADT is often successful in improving outcomes, but it also causes many difficult side effects including fatigue, sexual dysfunction, hot flashes, cognitive changes, metabolic dysregulation, and weight gain, negatively impacting men’s quality of life.

Using the ArteraAI Prostate Test on post-prostatectomy surgical specimens, patients in the trial will be risk-stratified into two groups: 1) low-risk patients who will be randomized to either 6 months of ADT or apalutamide monotherapy, which avoids the difficult side effects of testosterone suppression, thereby preserving their quality of life, and 2) high-risk patients who will be randomized to either 24 months of ADT or 6 months of ADT with apalutamide.

The trial’s primary endpoint will assess the patients’ general quality of life, using questionnaires and wearable devices. Secondary endpoints will include physician-reported toxicity, patient-reported activity, sleep, cognitive function, mental health, body composition changes, and cancer control metrics.

The primary site for the trial is MD Anderson Cancer Center, with up to 10 additional sites including Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, and OhioHealth. The trial is actively enrolling patients across sites.

To learn more or to enroll in the trial, visit: https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0409.html

About Artera

Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test.

Artera’s multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient’s biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials.

Artera’s laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera’s laboratory in Jacksonville, Florida, and can be ordered online at artera.ai.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250311717751/en/