"What ARASTEP is asking is how effective of a biomarker is PSMA PET/CT?" says Alexander M. Chehrazi-Raffle, MD.
In this video, Alexander M. Chehrazi-Raffle, MD, highlights the ongoing ARASTEP study (NCT05794906), which was featured during the 2024 ASCO Genitourinary Cancers Symposium in San Francisco, California with the abstract “Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP),”. Chehrazi-Raffle is a medical oncologist at City of Hope Comprehensive Cancer Center in Duarte, California.
Could you describe the background for this study?
ARASTEP is looking to build upon our current body of data in the biochemically recurrent space for patients who are deemed high-risk. As we've seen with studies such as EMBARK and PRESTO, and others, we've learned that adding another layer of therapy to these patients is beneficial. What ARASTEP is asking is how effective of a biomarker is PSMA PET/CT? We use it clinically, but nothing is yet to date been shown in a clinical trial setting that PSMA positive, conventional imaging negative patients are an additional layer of risk. ARASTEP seeks to answer that question.
How was the study designed? What are the key end points?
It's a phase 3 international randomized control trial, in which patients are either going to get standard of care at the time of trial design, which is ADT plus placebo for 24 months. That's going to be compared to ADT plus darolutamide for 12 months. The primary end point is actually rPFS per PSMA PET/CT. It's also, like I mentioned, only going to be a trial evaluating patients with known PSMA positive disease. So, it's a subset within the high-risk, biochemically recurrent space.
This transcription has been edited for clarity.