On March 11, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the first patient enrollment in PROSTATE-IQ, a Phase 3 clinical trial in men with prostate cancer recurrence after prostatectomy (Press release, Artera, MAR 11, 2025, View Source [SID1234651085]). 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.
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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: View Source