Dr. Chehrazi-Raffle highlights the phase 3 ARASTEP study


"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.

Video Transcript:

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.

Recent Videos
Blur image of hospital corridor | Image Credit: © whyframeshot - stock.adobe.com
DNA | Image Credit: © BillionPhotos.com - stock.adobe.com
Blurred interior of hospital | Image Credit: © jakkapan - stock.adobe.com
Quitting smoking - male hand crushing cigarette | Image Credit: © mbruxelle - stock.adobe.com
Blur image of hospital corridor | Image Credit: © whyframeshot - stock.adobe.com
Human kidney cross section on science background | Image Credit: © Crystal light - stock.adobe.com
Elisabeth M. Sebesta, MD, answers a question during a Zoom video interview
Related Content
© 2024 MJH Life Sciences

All rights reserved.