Clinical Follow-up Assessment

“Sixteen men aged 58 to 79 y with clinical stage T2a or less prostate cancer, Gleason score of 4+3 or less, and a minimum postablation follow-up of 12-mo endpoints were analyzed”

“All patients were diagnosed by MR-US fusion biopsy, including both targeted and systematic sampling, and had discrete MR-visible lesions without other foci of prostate cancer”

“mpMRI was obtained using a 3-Tesla phased array coil and classified using the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2). GSN-mediated laser ablation was performed within 4 mo of mpMRI acquisition”

“Regions of interest corresponding to the lesions detected on prior MR/US fusion biopsy were marked in preparation for GSN-mediated laser ablation. Region of interest selection and prostatic segmentation were performed, using DynaCAD software (InVivo, A Philips Healthcare Company, Best, Netherlands). An 8- to 10-mm margin of ablation around the target lesion or lesions was marked while avoiding critical nearby structures”

“Stereotactic trocar/laser fiber placement was planned, using an in-house-generated mockup of a transperineal stepper overlaid on the ablation and tumor regions of interest. To ensure complete coverage of the lesion(s), trocar/laser fiber insertion sites were placed ≈5 to 7 mm apart, considering a 4- to 5-mm treatment radius around the optical fiber diffuser”

“On treatment day 1, patients received a 7.5 mL/kg i.v. infusion of GSN (4.8 mg/mL) through a standard nonbis(2-ethylhexyl) phthalate infusion set at a rate of 120 to 600 mL/h”

“Before treatment on day 2, patients received a saline enema and single dose of Gentamicin 160 mg i.v. PB”

“Patients subsequently underwent laser illumination under general anesthesia while positioned in the dorsal lithotomy position”

“Periprostatic nerve block was performed using 1% lidocaine without epinephrine under transrectal ultrasound guidance via the perineum”

“In conjunction with a biplanar BK ultrasound 8848 probe, 14-gauge grid (CIVCO 610–977), and an EM-tracked MR/US fusion guidance platform with EM compatible stepper (UroNav, A Philips Healthcare company, Best, Netherlands), multiple 14G needle-guided introducers were placed transperineally”

“Once all introducers were in place, the trocars were removed just before the laser catheter was inserted sequentially into each trocar cannula, and near-infrared light (810 ± 10 nm) was delivered continuously for 3 min at a power level subablative in the absence of GSN”

“Depending on the cranio-caudal dimension of the intended ablation zone, consecutive laser activations took place after withdrawing the laser fiber, to allow for adequate coverage of the intended ablation zone. An 8-mm withdrawal was used for the 10-mm OFD, and 12-mm withdrawal for the 18-mm OFD”

“To monitor and minimize the risk for tissue damage near critical structures, needle thermocouples were placed near them when the intended ablation zone was in close proximity”

“As a control treatment, a single 3-min continuous laser excitation with the same laser power was performed at a location contralateral to the target lesion to evaluate whether or not ablation occurred in the absence of GSN”

“Patients were discharged on the same day of the procedure after several hours of monitoring and a successful voiding trial”

“At 48 to 72 h posttreatment, subjects underwent mpMRI to evaluate the radiologic treatment response at the planned ablation zone”

“Posttreatment follow-up was performed at 1, 3, 6, and 12 mo postablation. At each visit, a history and physical were performed to document any potential adverse events; in addition, patient IPSS and SHIM scores, PSA, and liver function tests were documented”

“At 3 and 12 mo, patients underwent repeat mpMRI and MR/US targeted biopsy, along with a 12-core systematic biopsy at 12 mo”

“Posttreatment follow-up was performed at 1, 3, 6, and 12 mo postablation. At each visit, a history and physical were performed to document any potential adverse events; in addition, patient IPSS and SHIM scores, PSA, and liver function tests were documented”

“At 3 and 12 mo, patients underwent repeat mpMRI and MR/US targeted biopsy, along with a 12-core systematic biopsy at 12 mo”

“First, the 6.3 ± 5.8 mg biopsy by mass was taken from the treatment zone to document the presence of nanoshells within each treated tumor. An elemental analysis was performed on each biopsy core, using Nuclear Activation Analysis”

“Second, the 48- to 72-h posttreatment DCE MRI helped to establish the volume of target tissue damage before necrotic reformation. This was compared with the minimal thermal ablation zone generated by the control treatment duplicating the laser dose in each patient, and was taken as confirmation that the applied laser dose was specific to tissues containing nanoshells”