PT - JOURNAL ARTICLE AU - Heying Duan AU - Pejman Ghanouni AU - Bruce Daniel AU - Jarrett Rosenberg AU - Alan Thong AU - Christian Kunder AU - Carina Mari Aparici AU - Guido A. Davidzon AU - Farshad Moradi AU - Geoffrey A. Sonn AU - Andrei Iagaru TI - A Pilot Study of <sup>68</sup>Ga-PSMA11 and <sup>68</sup>Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer AID - 10.2967/jnumed.122.264448 DP - 2022 Nov 01 TA - Journal of Nuclear Medicine PG - jnumed.122.264448 4099 - http://jnm.snmjournals.org/content/early/2022/11/17/jnumed.122.264448.short 4100 - http://jnm.snmjournals.org/content/early/2022/11/17/jnumed.122.264448.full AB - Purpose: Targeting of lesions seen on multiparametric MRI (mpMRI) improves prostate cancer (PC) detection at biopsy. However, 20–65% of highly suspicious lesions on mpMRI (PI-RADS 4 or 5) are false positives (FP), while 5–10% of clinically significant PC (csPC) are missed. Prostate specific membrane antigen (PSMA) and gastrin-releasing peptide receptors (GRPR) are both overexpressed in PC. We therefore aimed to evaluate the potential of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for biopsy guidance in patients with suspected PC. Methods: A highly selective cohort of 13 men, aged 58.0±7.1 years, with suspected PC (persistently high prostate-specific antigen [PSA] and PSA density) but negative or equivocal mpMRI and/or negative biopsy were prospectively enrolled to undergo 68Ga-PSMA11 and 68Ga-RM2 PET/MRI. PET/MRI included whole-body and dedicated pelvic imaging after a delay of 20 minutes. All patients had targeted biopsy of any lesions seen on PET followed by standard 12-core biopsy. Maximum standardized uptake values (SUVmax) of suspected PC lesions were collected and compared to gold standard biopsy. Results: PSA and PSA density at enrollment were 9.8±6.0 (1.5–25.5) ng/mL and 0.20±0.18 (0.06–0.68) ng/mL2, respectively. Standardized systematic biopsy revealed a total of 14 PC in 8 participants: 7 were csPC and 7 were non-clinically significant PC (ncsPC). 68Ga-PSMA11 identified 25 lesions, of which 11 (44%) were true positive (TP) (5 csPC). 68Ga-RM2 showed 27 lesions, of which 14 (52%) were TP, identifying all 7 csPC and also 7 ncsPC. There were 17 concordant lesions in 11 patients vs. 14 discordant lesions in 7 patients between 68Ga-PSMA11 and 68Ga-RM2 PET. Incongruent lesions had the highest rate of FP (12 FP vs. 2 TP). SUVmax was significantly higher for TP than FP lesions in delayed pelvic imaging for 68Ga-PSMA11 (6.49±4.14 vs. 4.05±1.55, P = 0.023) but not for whole-body images, nor for 68Ga-RM2. Conclusion: Our results show that 68Ga-PSMA11 and 68Ga-RM2 PET/MRI are feasible for biopsy guidance in suspected PC. Both radiopharmaceuticals detected additional clinically significant cancers not seen on mpMRI in this selective cohort. 68Ga-RM2 PET/MRI identified all csPC confirmed at biopsy.