The first patient has been enrolled in the phase 3 PROSTATE-IQ clinical trial, which aims to reduce the burden of hormone therapy in men with recurrent prostate cancer following prostatectomy. The study will evaluate the ArteraAI Prostate Test's ability to accurately identify patients who can safely reduce or avoid androgen deprivation therapy (ADT), potentially improving quality of life while maintaining treatment efficacy.
The trial, registered as NCT06274047, plans to enroll 120 patients across 11 clinical sites in the United States. Dr. Karen Elizabeth Hoffman, a professor of Radiation Oncology and director of the Mays Radiation Oncology Center at The University of Texas MD Anderson Cancer Center, is leading the investigation.
Personalizing Treatment Based on Risk Assessment
The PROSTATE-IQ trial will use the ArteraAI Prostate Test to analyze post-prostatectomy surgical specimens and stratify patients based on their risk of disease progression. Patients classified as low risk will be randomly assigned to either six months of ADT or apalutamide (Erleada) monotherapy. Those determined to be high risk will receive either 24 months of ADT or a combination of six months of ADT with apalutamide.
"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 Dr. Tim Showalter, 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."
Addressing the Side Effects of Hormone Therapy
While ADT is a standard component of treatment for recurrent prostate cancer, it often causes significant side effects that negatively impact patients' quality of life. These include fatigue, sexual dysfunction, hot flashes, cognitive changes, metabolic dysregulation, and weight gain.
The trial aims to determine whether apalutamide-based treatment can reduce these adverse effects while maintaining therapeutic efficacy. Apalutamide may help mitigate side effects associated with testosterone suppression, potentially preserving quality of life for patients.
Trial Eligibility and Design
Eligible participants must be over 18 years old with histologically confirmed prostate cancer and a prostate-specific antigen (PSA) level of 0.1 ng/mL or higher following radical prostatectomy. They must also have an ECOG performance status of 2 or lower, adequate organ function, and be candidates for salvage radiation and ADT treatment.
The primary outcome measure will assess general quality of life using questionnaires and wearable devices, including the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue). Secondary endpoints include physician-reported toxicity, patient-reported activity, sleep, cognitive function, mental health, body composition changes, and cancer control metrics.
About the ArteraAI Prostate Test
The ArteraAI Prostate Test is a multimodal artificial intelligence biomarker test that uses patients' digital biopsy images and clinical data to predict which patients may benefit from particular therapies. The test has been validated in various patient populations, including those undergoing active surveillance, radiation therapy, or radical prostatectomy.
Across all National Comprehensive Cancer Network risk groups, the test can assess the risk of 10-year distant metastasis and prostate cancer-specific mortality. In lower-risk patients, it can evaluate the relative risk of adverse pathology at radical prostatectomy to guide decisions about active surveillance. For intermediate-risk patients, it can predict the benefit of adding short-term ADT to radiation therapy.
Participating Clinical Sites
The primary site for the trial is The University of Texas MD Anderson Cancer Center, with additional participating institutions including Memorial Sloan Kettering Cancer Center in New York, Dana-Farber Cancer Institute in Boston, and OhioHealth in Columbus, among others.
The trial is actively enrolling patients, with primary completion expected by June 2027. Results from this study could potentially change the standard of care for men with biochemical recurrence after prostatectomy, allowing for more personalized treatment approaches that balance cancer control with quality of life considerations.
