Phase 3 trial launches of ArteraAI Prostate test for treatment selection

The first patient has been enrolled in the phase 3 PROSTATE-IQ trial (NCT06274047), assessing the ability of the ArteraAI Prostate Test to accurately identify patients who can safely reduce or avoid treatment with hormone therapy, Artera announced in a news release.¹

The PROSTATE-IQ trial plans to enroll 120 patients.

The goal of the trial is to improve quality of life for patients with low-risk disease by enabling them to reduce or avoid the adverse effects associated with androgen deprivation therapy (ADT). The study will include patients who have biochemical recurrence following prostatectomy.

“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.”

In total, the PROSTATE-IQ trial plans to enroll 120 patients at up to 11 clinical trial sites across the US.²

For the study, ArteraAI will be used to evaluate post-prostatectomy surgical specimens in order to stratify patients based on their risk. Patients deemed low risk will be randomly assigned to either 6 months of ADT or to apalutamide (Erleada) monotherapy. Those determined to be high risk will be randomly assigned to either 24 months of ADT or to 6 months of ADT with apalutamide.

The investigators will evaluate the ability to personalize treatment based on disease aggressiveness as well as determine whether apalutamide-based treatment can reduce fatigue and other adverse effects.

Patients are eligible for enrollment in the study if they have histologically confirmed prostate cancer, 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. Participants must also be older than 18 years and a candidate for salvage radiation and ADT treatment.

The primary outcome measure for the study is general quality of life, which according to Artera will be measured using questionnaires and wearable devices. This will include the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue). The company also noted, “Secondary end points will include physician-reported toxicity, patient-reported activity, sleep, cognitive function, mental health, body composition changes, and cancer control metrics.”

Primary completion of the trial is expected for June 2027.

ArteraAI is a multimodal artificial intelligence biomarker test that uses patients’ digital biopsy images and clinical data to help predict which patients may benefit from a particular therapy. The prognostic test has been validated in patients who have undergone active surveillance, radiation therapy, or had a radical prostatectomy.³

Across all National Comprehensive Cancer Network risk groups, the test can help to assess the risk of 10-year distant metastasis and prostate cancer-specific mortality. In lower-risk patients, the test can be used to evaluate the relative risk of adverse pathology at radical prostatectomy, to help guide decisions surrounding active surveillance. In intermediate-risk patients, the test can help predict the benefit of adding short-term ADT to radiation therapy.⁴

References

1. Artera announces 1st patient enrolled in PROSTATE-IQ trial to reduce burden of hormone therapy in men with prostate cancer recurrence after prostatectomy. News release. Artera. Published online and accessed March 11, 2025. https://www.businesswire.com/news/home/20250311717751/en/Artera-Announces-1st-Patient-Enrolled-in-PROSTATE-IQ-Trial-to-Reduce-Burden-of-Hormone-Therapy-in-Men-with-Prostate-Cancer-Recurrence-After-Prostatectomy

2. PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. ClinicalTrials.gov. Last updated November 12, 2024. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT06274047

3. Artera announces expansion of the ArteraAI Prostate Test to inform active surveillance decisions for lower risk prostate cancer patients. News release. Artera. August 6, 2024. Accessed March 11, 2025.https://www.businesswire.com/news/home/20240806340589/en/Artera-Announces-Expansion-of-the-ArteraAI-Prostate-Test-to-Inform-Active-Surveillance-Decisions-for-Lower-Risk-Prostate-Cancer-Patients

4. ArteraAI Prostate Test. Artera. Accessed March 11, 2025. https://artera.ai/for-clinicians