Using Ga-PSMA-11 PET/CT for Therapy Response Assessment in Patients with Metastatic Castration-Resistant Prostate Cancer: Application of EAU/EANM Recommendations in Clinical Practice.

For patients with metastatic castration-resistant prostate cancer (mCRPC), no reliable biomarkers for predicting therapeutic response or assisting in treatment selection and sequencing are currently available. Using the recent European Association of Urology and European Association of Nuclear Medicine recommendations, we aimed to compare response assessment between prostate-specific membrane antigen (PSMA) PET/CT and conventional imaging in mCRPC patients starting first-line treatment with a novel hormonal agent (NHA) and to perform a sequential comparative analysis of PSMA PET/CT-derived parameters after 4 and 12 wk of therapy. Data from 18 mCRPC patients who started NHA treatment and underwent Ga-PSMA-11 PET/CT before therapy initiation (baseline), at week 4 (W4), and at week 12 (W12) in addition to conventional imaging (bone scintigraphy, CT) at baseline and W12 were retrospectively included. PET/CT images were quantitatively analyzed for maximum and mean SUV and total PSMA ligand-positive lesions. Comparative analysis of PET/CT-derived parameters was performed, and patients were classified as having nonprogressive disease or progressive disease (PD) according to Ga-PSMA-11 PET/CT, prostate-specific antigen, and conventional imaging criteria. Treatment response was evaluable by Ga-PSMA-11 PET/CT in 16 of 18 patients (89%) and by conventional imaging in 11 of 18 patients (61%). Five of 16 patients classified as having PD by Ga-PSMA-11 PET/CT at W12 had already met progression criteria at W4, and substantial agreement was observed between W4 and W12 (κ, 0.74) Ga-PSMA-11 PET/CT results. Nonetheless, 2 of 16 patients (13%) were incorrectly classified as having PD because of a flare phenomenon on PSMA PET/CT that disappeared at W12. Volumetric assessments of Ga-PSMA-11 PET/CT imaging can improve response evaluation in NHA-treated patients with mCRPC. Although early response assessments at W4 need to be approached with caution because of flare, Ga-PSMA-11 PET/CT imaging at W4 and W12 revealed substantial agreement in therapy response assessments; these findings warrant further investigation to distinguish PD from flare at W4 and help improve the understanding of resistance to therapy.