Active clinical trials for "Prostatic Neoplasms"

Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.

The main idea behind MICRO-LEARNER is to provide new insights about the response of healthy tissues to radiation by using information from the micro-environment obtained by biological measurements and imaging. This new knowledge will be included in current available predictive models of radio-induced toxicity, thus allowing to add unique biological characteristics of patients to dosimetry and treatment/clinical related variables. MICRO-LEARNER focuses on prostate cancer (PCa) and head-and-neck cancer (HNCa). For both cancers, radiotherapy is effectively used as curative treatment, in single modality or within a multidisciplinary approach including surgery (PCa) and/or chemotherapy (HNCa). Prediction and reduction of radio-induced side effects are becoming a priority: for PCa, high survival rates should be accompanied by a very low rate of moderate/severe toxicities; for HNCa, there is the need to tailor radiation dose according to disease recurrence risk profile. The shared aim of both cancers is to balance the improvement in outcome with a well-tolerated toxicity profile. Recent research indicates that the intestinal/salivary bacteria are strongly suspected of being very important in mediating the response to inflammation and lesions. Although their balance deeply changes during radiotherapy, studies done so far in the field of the microbiota-host relationship in radiotherapy have not addressed their role in insurgence of radiation toxicity. In this study, the investigators will assess how microbial populations evolve and how this influences the host and radiation induced toxicity in a significant number of patients. Moreover, the individual response at the tissue microstructure level, through analysis of images with advanced bioengineering techniques, will be determined. Results from this research, besides suggesting new ways to predict patients at risk of relevant side-effects, may also suggest possible treatments to change the baseline microbiota of patients at high risk or to modify it during therapy, in order to mitigate toxicity. Understanding the microbiota-radiotherapy interaction may thus lead to novel, effective and inexpensive ways of assessing and managing complications of cancer treatment.

The ANTELOPE trial is a longitudinal observational clinical study of changes in bone density, structure and strength over 12 months in men receiving treatment for prostate cancer. Three groups (n = 30 per group) will be compared, with bone assessments at baseline and 12 months. Allowing for a 18 month recruitment period, 12 months follow-up and data analysis, the total study length will be 3 years. The groups comprise: Group A - Men with prostate cancer starting ADT Group B - Men with newly diagnosed hormone sensitive metastatic prostate cancer, about to start (or have started within the past 3 months) ADT and who will undergo chemotherapy with docetaxel and prednisolone Group C - Age-matched men without prostate cancer

PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide

In this project, we would like to focus on castration-sensitive prostate cancer (CRPC). This is a highly variable clinical picture with differentiated and burdening symptoms. The clinical parameters used to estimate the prognosis have so far only shown a very limited valence; genetic markers have so far only rarely been investigated. In the course of our preliminary investigations, we were already able to isolate 189 plasma samples from 59 patients with metastatic prostate cancer. These samples are prepared by highly innovative techniques, e.g. "whole genome sequencing", in order to gain comprehensive insights into the spectrum of genetic changes under therapy and the associated tumor evolution. These results should be compared with the genetic material of the respective prostate tumors, which originate from previous operations. This highly comprehensive data, which will yield results on copy number changes, mutations, and gene expression, will allow analysis of signaling pathways of unprecedented resolution to increase the efficacy of targeted therapies in patients and minimize the burden of non-effective therapy side effects.

This is a double-blind, study to evaluate the performance of NV-VPAC1 PCa Urine Diagnostic Test in three distinct populations being treated at the Intermountain Urology Clinic. The first population (positive control) is comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. The second population (negative control) is comprised of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). The third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.

Investigators will conduct a randomized trial to determine if providing patient-specific life expectancy estimates during treatment counseling via a targeted, patient-centered communication approach improves shared decision making and reduces rates of overtreatment of genitourinary malignancies.

Rationale: Current imaging techniques for the detection and grading of prostate cancer are imperfect, leading to unnecessary biopsies, suboptimal treatment decisions and missed clinically significant cancers. The hypothesis of this study is that computer assisted analysis of 3D multiparametric ultrasound (mpUS) images can accurately detect, grade and localize prostate cancer. 3D mpUS may then become a more cost-effective and more streamlined imaging strategy than the current standard: mpMRI. Objective: The primary objective is to collect high-quality 3D mpUS and histology data, to train and improve the classifier algorithm with the goal of achieving an accurate ultrasound imaging tool for the detection of clinically significant prostate cancer. Secondary objectives are related to the preliminary assessment of the performance of 3D mpUS with computer assisted analysis. Study design: This is a prospective, multi-center study in men with a suspicion of prostate cancer who are scheduled for prostate biopsies, and men with confirmed prostate cancer who are scheduled to undergo a radical prostatectomy. Prior to prostate biopsies or the radical prostatectomy, 3D mpUS imaging will be performed. The ultrasound images will be analyzed and used for algorithm training using the biopsies and/or prostatecomy specimens as gold standard. Additional research coupes of pathology material (both biopsies and radical prostatectomy specimens) from study subjects will be anonymized and separately analyzed and stored in a central, independent institution. The outcome of the 3D mpUS analysis and the additional pathology evaluation are for research purposes only and will not interfere with standard patient care. Study population: 1) Male patients of age ≥18 suspected for prostate cancer who are scheduled for systematic and/or targeted biopsy after mpMRI examination. 2) patients of age ≥18 with confirmed prostate cancer who are scheduled for radical prostatectomy. Main study parameters/endpoints: Gleason/Grade group scoring based on histology. Using histology as the reference standard the accuracy of the algorithm will be optimized to be differentiating between benign tissue and various grades of malignancy. Localization and size of lesions at full-gland histology in the subset of patients undergoing radical prostatectomy. Correlation in tumour size and location will be optimized between 3D mpUS findings and histology of the full gland. For the secondary objective, preliminary assessment of the performance of 3D mpUS, the following endpoints are evaluated Among all clinically significant detected cancers confirmed by histology, the proportion of these cancers that would have been detected by 3D mpUS will be calculated. The number of false positive findings by 3D mpUS both as an absolute count and expressed as a mean rate per patient. The concordance in the detection and grading of abnormalities between mpMRI and 3D mpUS by examining the frequency and type of disagreements and calculating the kappa statistic.

Prostate carcinoma (PC) is common malignancy and is considered to be the highest incidence in the old males. The traditional diagnostic methods of PC present with some shortcomings. For example, the specificity of serum PSA remains low while prostate needle biopsy is invasive and false negative in some case, even causing missed diagnosis of some high risk PC, and over diagnosis of PC is not rare. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed. Our previous study has proved that PROstate cancer Urine Detector (PROUD), which is able to detect chromosomal aberrations of the urine exfoliated cells, is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential in PC diagnosis hasn't been assessed yet and the accuracy of PROUD in detecting PC need to be validated. We here intended to investigate whether PROUD can be used in PC diagnosis and further validate the accuracy of PROUD in diagnosing PC.

This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functional results) of the robot-assisted laparoscopic radical prostatectomy compared with other procedures using real-life data from SNDS. The population of patients who benefited from robot-assisted surgery will be identified in the SNDS through a practices survey, allowing the identification of centres fully converted to robotics.