Practical radiation oncology · 2026
Androgen Deprivation Therapy (ADT) and Radiotherapy (RT) with Imaging Evaluation Longitudinally (ARIEL) trial: protocol, early results, and implications of neoadjuvant ADT for focal RT boost in prostate cancer.
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Song Yuze, Domingo Mariluz Rojo, Nguyen Lily, Conlin Christopher C, Dhillon Nitin, Do Son, Dornisch Anna, Hahn Michael E, Karunamuni Roshan, Kim Joshua, Lee Kang-Lung, Liu Jasmine, McKay Rana R, Mell Loren K, Mundt Arno J, Patel Rakesh, Qiao Edmund M, Rose Brent, Rupareliya Rhea, Schaub Hadley, Schwartzman Armin, Stewart Tyler, Dale Anders M, Seibert Tyler M, ARIEL investigators
Аннотация
PURPOSE: Men with aggressive, localized prostate cancer (PC) undergo definitive radiotherapy (RT) with androgen deprivation therapy (ADT). The prospective, phase II ARIEL trial evaluates a quantitative MRI biomarker, Restriction Spectrum Imaging restriction score (RSIrs), at three time points (before treatment, after ADT, and after RT) for treatment response assessment. RSIrs is correlated with high-grade PC.
METHODS AND MATERIALS: Men with unfavorable-intermediate-risk or high-risk localized PC undergo definitive RT with ADT, and MRI-RSI acquisitions before therapy, after neoadjuvant ADT but before RT, and after RT. The primary aim is to evaluate performance of RSIrs for identifying patients who will experience early biochemical recurrence. Change in RSIrs within tumors after ADT and RT is the primary independent variable.
RESULTS: 97 patients met inclusion criteria. Visible PI-RADS lesions were identified in 88 patients: 80 patients had one lesion, and 8 patients two lesions. After neoadjuvant ADT, 40% of lesions were not visible. Visible lesions shrank by median 55.8% (IQR: 42.8-69.0%), while prostate volume decreased 21.5% (11.9-31.6%). RSIrs maximum within lesions decreased from mean 329 (SD:185) pre-ADT to 209 (SD:125) pre-RT, and 107 (SD:61) post-RT. Follow-up is ongoing to assess whether imaging response is related to future recurrence.
CONCLUSION: ARIEL has completed accrual and preliminary results demonstrate changes in RSIrs after treatment, which may indicate tumor response. Primary results will be presented when the primary endpoint is reached. With neoadjuvant ADT, both pre- and post-ADT MRI are likely necessary for accurate focal RT boost. Concurrent commencement of ADT and RT facilitates accurate gross tumor volume delineation.
METHODS AND MATERIALS: Men with unfavorable-intermediate-risk or high-risk localized PC undergo definitive RT with ADT, and MRI-RSI acquisitions before therapy, after neoadjuvant ADT but before RT, and after RT. The primary aim is to evaluate performance of RSIrs for identifying patients who will experience early biochemical recurrence. Change in RSIrs within tumors after ADT and RT is the primary independent variable.
RESULTS: 97 patients met inclusion criteria. Visible PI-RADS lesions were identified in 88 patients: 80 patients had one lesion, and 8 patients two lesions. After neoadjuvant ADT, 40% of lesions were not visible. Visible lesions shrank by median 55.8% (IQR: 42.8-69.0%), while prostate volume decreased 21.5% (11.9-31.6%). RSIrs maximum within lesions decreased from mean 329 (SD:185) pre-ADT to 209 (SD:125) pre-RT, and 107 (SD:61) post-RT. Follow-up is ongoing to assess whether imaging response is related to future recurrence.
CONCLUSION: ARIEL has completed accrual and preliminary results demonstrate changes in RSIrs after treatment, which may indicate tumor response. Primary results will be presented when the primary endpoint is reached. With neoadjuvant ADT, both pre- and post-ADT MRI are likely necessary for accurate focal RT boost. Concurrent commencement of ADT and RT facilitates accurate gross tumor volume delineation.