<p><strong> </strong><strong>In mCRPC patients with disease progression following treatment with an ARPI (with or without prior docetaxel), and a positive PSMA PET/CT, clinicians should offer <sup>177</sup>Lu-PSMA-617. (<em>Strong Recommendation; Evidence Level Grade: B</em>)</strong></p>
Discussion
Discussion
<p>In the phase III VISION trial, patients with progressive mCRPC and PSMA PET avid disease following therapy with an ARPI and docetaxel treated with <sup>177</sup>Lu-PSMA-617 plus SOC had improved PFS and OS<sup> </sup>compared to patients receiving SOC alone at a median follow-up of approximately 21 months.<sup>126</sup> This study led to the approval of <sup>177</sup>Lu-PSMA-617 for progressive mCRPC in 2022.</p>
<p>More recently, <sup>177</sup>Lu-PSMA-617 was evaluated in the chemotherapy-naïve mCRPC setting. The phase III multi-national PSMAfore trial<sup>127</sup> randomized patients who had progressed on prior ARPI to <sup>177</sup>Lu-PSMA-617 or change of ARPI and evaluated time from randomization to radiographic progression or death. Results indicated a median rPFS of 9.3 months versus 5.55 months in the <sup>177</sup>Lu-PSMA-617 versus ARPI change group, respectively. Importantly, there was a favorable safety profile with a low incidence of high-grade adverse events in the treatment arm.</p>