Perirectal hydrogel spacer placement prior to prostate radiation therapy using a probe-mounted needle guide.

In this report we describe our successful adoption of a single-use, probe-mounted, needle guide for perirectal hydrogel spacer placement prior to radiation therapy for prostate cancer. Use of this device eliminates the need for a mechanical stepper unit and facilitates perirectal hydrogel placement by ensuring alignment of the injection needle with the ultrasound probe.

Clinical Predictors of Early Trial Discontinuation for Patients Participating in Phase I Clinical Trials in Oncology.

Despite stringent eligibility criteria for trial participation, early discontinuation often occurs in phase I trials. To better identify patients unlikely to benefit from phase I trials, we investigated predictors for early trial discontinuation. Data from 415 patients with solid tumors who participated in 66 trials were pooled for the current analysis. Early trial discontinuation was defined as (i) trial discontinuation within 28 days after start of treatment or (ii) discontinuation before administration of the first dosage in eligible patients. Multilevel logistic regression analyses were conducted to identify predictors for early trial discontinuation. Eighty-two participants (20%) demonstrated early trial discontinuation. Baseline sodium level below the lower limit of normal (OR = 2.95, 95%CI = 1.27-6.84), elevated alkaline phosphatase level > 2.5 times the upper limit of normal (OR = 2.72, 95%CI = 1.49-4.99), performance score ≥ 1 (OR = 2.07, 95%CI = 1.03-4.19) and opioid use (OR = 1.82, 95%CI = 1.07-3.08) were independent predictors for early trial discontinuation. Almost 50% of the patients with hyponatremia and all four patients in whom all four predictors were present together discontinued the trial early. Hyponatremia, elevated alkaline phosphatase level, performance score ≥ 1 and opioid use were identified as significant predictors for early trial discontinuation. Hyponatremia was the strongest predictor and deserves consideration for inclusion in eligibility criteria for future trials.

Toxicological evaluation of biosynthesised hematite nanoparticles in vivo.

In recent years, nanomaterials have been widely used in consumer products. High reactivity of metallic nanoparticles and its bioaccumulation in biological systems are the main causes of concern over their safety to human health and environment. The available information related to the safety of several nanomaterials is insufficient. Hematite nanoparticles are proposed for various applications. Ecotoxicological studies of hematite nanoparticles are very limited. In the present study, biosynthesised hematite nanoparticles using Bacillus cereus were evaluated for its acute oral toxicity in mice following OECD guidelines. A dose of 2 g/kg/p.o was administered to Swiss albino mice through gastric oral feeding tube and observed for 14 days. After two weeks blood samples were collected and subjected for evaluation of haematological parameters and biochemical analysis. There was no mortality and toxic signs of animals till the end of observational period. The animals were sacrificed and organs like liver and kidneys were isolated to study the histopathological changes. The results of the study revealed that there was no drastic change in parameters except slight change in bilirubin in the hematite nanoparticle treated mice. Biosynthesised hematite nanoparticles were assayed for toxicity in Artemia salina. Cysts treated with higher concentrations of hematite nanoparticles showed small sized nauplii. Biosynthesised hematite nanoparticles were found to be non-toxic to A. salina nauplii in lower concentrations.

Association of SPOP Mutations with Outcomes in Men with De Novo Metastatic Castration-sensitive Prostate Cancer.

Recently, mutations in speckle-type pox virus and zinc finger protein (SPOP) gene (mutant SPOP [mtSPOP]) have been associated with improved outcomes to abiraterone in the castration-resistant setting. We hypothesized that mtSPOP would be associated with improved outcomes to systemic therapy in men with de novo metastatic castration-sensitive prostate cancer (d-mCSPC). Retrospective data of newly diagnosed d-mCSPC patients were collected from four institutions. Eligibility criteria included standard androgen deprivation therapy without intensification, and SPOP mutational status (mtSPOP or wild-type SPOP [wtSPOP]) determination by targeted next-generation sequencing from tumor biopsies. A total of 121 men (25 mtSPOP [21%] and 96 wtSPOP [79%]) were included. After adjusting for covariates, mtSPOP was significantly associated with better median progression-free survival (35 vs 13 mo; adjusted hazard ratio [HR] 0.47; p = 0.016) and overall survival (97 vs 69 mo; adjusted HR 0.32; p = 0.027), with similar HR and p value on the univariate analysis. These findings, upon external validation, may assist with counseling and prognostication in the clinic, and inform the design of future clinical trials in this setting. PATIENT SUMMARY: : Presence of tumor mutation in speckle-type pox virus and zinc finger protein (SPOP) gene was associated with improved survival outcomes in men with de novo metastatic castration-sensitive prostate cancer receiving standard androgen deprivation therapy.