Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 28, 2015
Actual date on which the first participant was enrolled.Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data. The following information will be collected for all patients: * Demographic data: date of birth, age, gender, ethnicity, Height, weight. * Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests. For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected: * MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values. * Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable). For patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected: * Procedure details. * Evaluation of success: results of following PSA test, MRI and/or prostate biopsy. Patients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives