MiraDx, a molecular diagnostics company advancing personalized medicine through novel germline biomarkers, has officially revealed the results from a groundbreaking study published in the journal Clinical Cancer Research.
Led by researchers at UCLA’s Department of Radiation Oncology, the stated study effectively confirms effectiveness of PROSTOX ultra, which is also the world’s first ever test to predict long-term radiation side effects based on a patient’s unique genetic profile.
All in all, these findings treads up a long distance to reinforce that radiation toxicity is a biologically unique response for each patient, thus relaying the potential to personalize and improve cancer treatment using genetics.
“Advancements in radiation technology, treatment planning, patient care, and follow-up make it challenging to directly compare toxicity between older and more modern treatment approaches,” said Amar Kishan, M.D., primary investigator of the study and Radiation Oncologist at UCLA. “Despite these challenges, this study validated PROSTOX ultra as a predictive biomarker, and that a genetic predisposition to increased toxicity persists with modern, high-precision SBRT, including MRI-guided SBRT. This finding reinforces PROSTOX ultra as a true measure of the biological response to radiation, independent of treatment era or technique that can identify the safest course of treatment to avoid toxicity.”
Before we dig any further into the results, we must take into account how prostrate cancer presently affects more than a quarter of a million individuals on an annual basis, primarily those over 65 years of age.
From that lot, radiation-induced toxicity remains a significant concern, with late-onset side effects occurring in 15-20% of patients. The most problematic, however, would be late GU toxicity, which includes symptoms, such as urinary tract pain, blood in urine, increased frequency of urination, or urinary urgency or leaking.
In case that wasn’t bad enough, many of whom live for decades post-treatment, late-onset side effects can persist, become extremely costly to manage, as well as significantly impact their quality of life.
In response, PROSTOX ultra arrives on the scene bearing an ability to analyze microRNA single-nucleotide polymorphisms (mirSNPs) in non-coding germline DNA. You see, it identifies patients at higher genetic risk of developing late grade ≥2 genitourinary (GU) toxicity after stereotactic body radiation therapy (SBRT).
More on that would reveal how PROSTOX ultra makes it possible for patients and clinicians to take more informed treatment choices and minimize side effects, while simultaneously prioritizing long-term quality of life and health outcomes.
“While severe side effects are uncommon, approximately 15-20% patients do develop moderate toxicity that could require medication and impact quality of life. This underscores the importance of being able to assess a patient’s unique biological suitability for SBRT, since that can influence their risk for long-term side effects,” said Luca Valle, M.D., study investigator and Radiation Oncologist at UCLA. “Fortunately, tools like PROSTOX ultra can help us to individualize and personalize our radiation treatment recommendations and reduce the risk of treatment-related toxicity.”
Talk about the study in question, it would recruit 148 patients for the Phase 3 MIRAGE clinical trial (Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer, NCT 04384770). As for the results, they confirmed PROSTOX ultra as an effective biomarker to predict late GU toxicity after SBRT.
Furthermore, the study revealed a strong correlation between the PROSTOX ultra score and toxicity grade. Not just that, this whole exercise also identified three separate temporal radiation-induced GU toxicity profiles i.e. acute only, chronic, and late.
These results, in essence, support the potential of mirSNP-based biomarkers to independently predict different types of toxicity risks before radiation therapy, regardless of clinical factors, such as age or radiation delivery technique.
“These findings represent a very important moment in the treatment of prostate cancer and for the field of oncology treatment as a whole,” said Joanne Weidhaas, M.D., Ph.D., study author, Professor at the David Geffen School of Medicine at UCLA and head of translation research in the Department of Radiation Oncology, and co-founder of MiraDx and founder of MiraKind. “PROSTOX ultra is the first test that predicts radiation toxicity, giving patients and their physicians important information to make decisions that balance effectiveness with long-term quality of life.”
