First Patient Enrolled in Phase 3 Recurrent Prostate Cancer Trial

The first patient has been enrolled in the phase 3 PROSTATE-IQ clinical trial being conducted in men with prostate cancer recurrence following a prostatectomy, according to a news release published by Artera.

The clinical trial is utilizing the ArteraAI Prostate Test which will determine cancer metastasis risk and identify whether patients may be able to reduce or avoid hormone therapy, in turn, enabling treatment personalization.

“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,” Dr. Tim Showalter, chief medical officer of Artera stated in the news release. “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.”

Dr. Karen Elizabeth Hoffman, a professor of Radiation Oncology and director of the Mays Radiation Oncology Center Medical at The University of Texas MD Anderson Cancer Center, in Houston, is leading the trial.

More About the Phase 3 Trial

The current standard of care for patients with recurrent prostate cancer is radiation, which the news release states is oftentimes combined with a hormone therapy called androgen deprivation therapy (ADT). Although ADT often provides a successful improvement in outcomes, it often causes difficult side effects including fatigue, sexual dysfunction, hot flashes, cognitive changes, metabolic dysregulation and weight gain, all of which negatively impact these patients' quality of life.

In the PROSTATE-IQ trial, the ArteraAI Prostate Test will be used to analyze post-prostatectomy surgical specimens and will then stratify patients into two risk groups. The first group will consist of low-risk patients who will be randomized to receive either six months of ADT or Erleada (apalutamide) monotherapy. The latter helps to mitigate the side effects which are associated with testosterone suppression, thereby maintaining quality of life. The second group will include high-risk patients who will be randomized to either 24 months of ADT or a combination of six months of ADT with Erleada.

According to the official study information page published at clinicaltrials.gov, eligible participants must be over 18 years old. Additionally, these patients must have histologically confirmed prostate cancer; a prostate-specific antigen level of 0.1 or more following radical prostatectomy; and be candidates for salvage radiation and ADT as determined by their physician. Furthermore, patients should have an ECOG performance status of 2 or more and demonstrate adequate organ function based on hematologic, renal and hepatic parameters.

Participants are ineligible for trial enrollment if they have used post-prostatectomy testosterone suppression before registration, except for those with testosterone recovery. Those with a history of seizures, certain cardiovascular events within six months, uncontrolled hypertension, active infections, gastrointestinal absorption disorders or confirmed extrapelvic or bone disease are excluded from enrollment. Individuals with prior or concurrent malignancies may be eligible if their condition does not impact the study’s safety or efficacy assessments.

Furthermore, the news release shared that the primary site for the trial is The University of Texas Anderson Cancer Center. There are also 10 additional sites which are conducting the trial including Memorial Sloan Kettering Cancer Center in New York, New York; Dana-Farber Cancer Institute in Boston, Massachusetts; and OhioHealth, in Columbus.

The primary end point of the investigation will assess the general quality of life of patients, using questionnaires and wearable devices to inform these outcomes. Physician-reported toxicity, patient-reported activity, sleep, cognitive function, mental health, body composition changes and cancer control metrics make up the secondary end points of the trial.

The clinical trial is actively enrolling patients across sites.

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