Gold nanoshell-localized photothermal ablation of prostate tumors in a clinical pilot device study.

Biocompatible gold nanoparticles designed to absorb light at wavelengths of high tissue transparency have been of particular interest for biomedical applications. The ability of such nanoparticles to convert absorbed near-infrared light to heat and induce highly localized hyperthermia has been shown to be highly effective for photothermal cancer therapy, resulting in cell death and tumor remission in a multitude of preclinical animal models. Here we report the initial results of a clinical trial in which laser-excited gold-silica nanoshells (GSNs) were used in combination with magnetic resonance-ultrasound fusion imaging to focally ablate low-intermediate-grade tumors within the prostate. The overall goal is to provide highly localized regional control of prostate cancer that also results in greatly reduced patient morbidity and improved functional outcomes. This pilot device study reports feasibility and safety data from 16 cases of patients diagnosed with low- or intermediate-risk localized prostate cancer. After GSN infusion and high-precision laser ablation, patients underwent multiparametric MRI of the prostate at 48 to 72 h, followed by postprocedure mpMRI/ultrasound targeted fusion biopsies at 3 and 12 mo, as well as a standard 12-core systematic biopsy at 12 mo. GSN-mediated focal laser ablation was successfully achieved in 94% (15/16) of patients, with no significant difference in International Prostate Symptom Score or Sexual Health Inventory for Men observed after treatment. This treatment protocol appears to be feasible and safe in men with low- or intermediate-risk localized prostate cancer without serious complications or deleterious changes in genitourinary function.

A cohort of transperineal electromagnetically tracked magnetic resonance imaging/ultrasonography fusion-guided biopsy: assessing the impact of inter-reader variability on cancer detection.

OBJECTIVE: To evaluate the ability to detect clinically significant prostate cancer (PCa) using a novel electromagnetically (EM) tracked transperineal magnetic resonance imaging (MRI)/ultrasonography (US) fusion-guided targeted biopsy (transperineal TBx) platform and the impact of inter-reader variability on cancer detection. MATERIALS AND METHODS: A total of 176 patients with suspicious lesions detected on multiparametric MRI (mpMRI) underwent a systematic modified Barzel template biopsy (12-core) transperineal biopsy (transperineal SBx) and transperineal TBx with EM tracking (UroNav; Philips Healthcare, Best, the Netherlands) in the same setting. Cancer detection rates (CDRs) were stratified by Prostate Imaging Reporting and Data System (PI-RADS) v2 scores and compared with Fisher's exact test. Area under the curve (AUC) was calculated for prostate-specific antigen (PSA), PSA density (PSAD), PI-RADS score, and subgroup analysis of individual readers' PI-RADS scores with respect to overall CDR and clinically significant CDR. RESULTS: The overall CDR was 76.7% (135/176), of which 76.3% (103/135) was clinically significant PCa. Among the 135 patients with PCa, transperineal TBx detected 90.4% of cases (122/135), either alone or in combination with transperineal SBx. The remaining 9.6% of cases (13/135) missed by transperineal TBx were diagnosed by transperineal SBx alone, of which three were clinically significant. Conversely, transperineal SBx missed 14% of cases (19/135), 14 of which were clinically significant PCa. Sensitivities for transperineal TBx and transperineal SBx were 90.4% and 85.9%, respectively. On a per-lesion basis, PI-RADS score (AUC 0.74) outperformed both PSA (AUC 0.59) and PSAD (AUC 0.63) in discriminating clinically significant from non-clinically significant PCa on transperineal TBx. Although not formally statistically tested, AUCs amongst different mpMRI readers appeared to display considerable variability. There were no adverse events, including sepsis. CONCLUSIONS: Electromagnetically tracked transperineal TBx of MRI-visible lesions enhanced the ability of transperineal SBx to detect PCa, with greater sensitivity for clinically significant disease. These findings suggest transperineal TBx is a safe, alternative fusion platform for patients with a suspicious lesion on prostate MRI. The assessment of inter-reader variability, in conjunction with prediction of clinically significant PCa and CDR, is an important first step for quality control in implementing an MRI-based screening programme.

Transperineal Versus Transrectal Targeted Biopsy With Use of Electromagnetically-tracked MR/US Fusion Guidance Platform for the Detection of Clinically Significant Prostate Cancer.

OBJECTIVE: To compare transperineal (TP-TBx) and transrectal (TR-TBx) targeted prostate biopsy in a prospective non randomized single surgeon series of MR/US fusion-guided targeted biopsy performed using an electromagnetic tracking platform (NCT04026763). MATERIALS AND METHODS: In this single-institution prospective study, 168 patients who underwent transperineal systematic 12-core biopsy and TP-TBx with electromagnetic tracking (UroNav, Invivo, Gainesville, FL) were compared to 211 patients who underwent a similar procedure by a transrectal approach. Univariate and multivariate analyses were used to assess if biopsy technique impacted all cancer detection rates or clinically significant (Gleason score >3+4) cancer detection rates. RESULTS: Patients who underwent TP-TBx were older (68 vs 65 y, P = .014), with a slightly higher rate of PI-RADSv2.0 score (39% vs 28%, P = .039) and higher lesion volume on mpMRI (0.54 vs 0.41 cc, P = .039). The rates of CS disease detection by TP-TBx and TR-TBx were 59% and 54%, respectively. In a multivariate analysis adjusting for PSA, previous biopsy status, prostate volume, PI-RADS score, lesion volume, and lesion location, there was no statistically significant difference in likelihood to detect any PCa (OR, 0.98; 95% CI, 0.56-1.71; P = .940) or CS PCa (OR, 0.94, 95% CI, 0.58-1.51; P = .791). CONCLUSION: Transperineal targeted biopsy with electromagnetic-tracking is comparable to the transrectal fusion-guided approach in the detection of any PCa and csPCa cancer.

Unmet informational and supportive care needs of patients following cystectomy for bladder cancer based on age, sex, and treatment choices.

PURPOSE: Assessing the unmet needs of cancer patients can help providers tailor health care services to patients' specific needs. This study examines whether the unmet informational and supportive care needs of the patients with muscle-invasive bladder cancer vary by the patients' age, sex, or individual treatment choices. METHODS AND MATERIALS: Participants (N = 30 survivors; 73.3% men) were recruited from the Mount Sinai Medical Center and through advertisements posted on a national Bladder Cancer Advocacy Network website between December 2011 and September 2012. Data were collected through individual interviews and electronic medical record review. A prior qualitative study of this cohort, using immersion/crystallization approach, confirmed the prevalence of unmet needs across the disease trajectory. This is a secondary quantitative analysis of the initial interview data we collected (i.e., quantitative analyses of transformed qualitative data using Chi-square and Fisher exact tests) to examine differences in unmet needs based on the patient's age, sex, and treatment choices. RESULTS: Younger patients (<60y) were less satisfied with the treatment information received presurgery and more likely to report posttreatment complications, choose a neobladder, and seek and receive professional support regarding sexual function, than were older patients (P<0.05). More women than men reported difficulties with self-care and relied on themselves in disease self-management as opposed to relying on spousal support (P<0.05). Patients with neobladder were more likely to report difficulties with urinary incontinence and deterioration in sexual function, whereas patients with ileal conduit were more likely to require spousal help with self-care. Patients who received chemotherapy were significantly more likely to report changes in everyday life (P<0.05). Lastly, regardless of age, sex, or treatment choice, up to 50% of patients reported feeling depressed before or after treatment. CONCLUSIONS: Unmet informational and supportive needs of patients with muscle-invasive bladder cancer during survivorship, and vary by age, sex, and treatment choices. Educational and psychological assessments as well as clinical interventions should be tailored to a patient's specific unmet needs, and to specific clinical and demographic characteristics.