(UroToday.com) The 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Annual Symposium held in San Francisco, CA was host to a renal cell, adrenal, penile, testicular, and urethral cancers trials-in-progress poster session. Dr. Suzanne Cole presented the ongoing EA8211-SOAR phase III randomized trial of stereotactic ablative radiotherapy (SAbR) for oligometastatic advanced renal cell carcinoma (omRCC).
Dr. Cole noted that optimal strategies for managing omRCC remain uncertain. While systemic therapy (ST) is the standard approach, SAbR shows promise as a potential alternative. SAbR could reduce systemic therapy-related toxicity, but the risk of undetected micro-metastatic progression is a concern. A prospective ECOG-ACRIN phase III randomized non-inferiority trial will compare SAbR with systemic therapy in omRCC patients.
The study schema is shown below. Patients with IMDC favorable or intermediate risk omRCC (2–5 lesions – all amenable to SAbR) and who had their primary site addressed by surgery will undergo 1:1 randomization to:
- Arm A: Sequential SAbR to all sites of metastases, with standard of care systemic therapy reserved for progression on SAbR
- Arm B: Standard of care systemic therapy
The co-primary endpoints are:
- Overall survival (OS)
- Grade ≥3 toxicity.
The study will be powered at 85% to test non-inferiority for OS (null HR=1.24; alternative=0.85). If overall survival is non-inferior, toxicity superiority will be tested.
Secondary endpoints include:
- Quality of life, assessed using NFKSI-19 and EQ-5D-5L
- Progression-free survival (PFS).
Exploratory endpoints are:
- Cost-effectiveness
- ctDNA.
The study's accrual goal is 472 participants.
Presented by: Suzanne Cole, MD, Associate Professor in the Division of Hematology and Oncology, Department of Internal Medicine at UT Southwestern Medical Center, Dallas, TX
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025.