Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.

Subjects will be placed in the dorsal lithotomy position, under sterile technique. The NanoKnife procedure will be carried out under general anesthesia. A Foley catheter will be placed to aid in draining the bladder during treatment.

NanoKnife Procedure

The purpose of this study is to evaluate the feasibility and short-term safety and effectiveness of the NanoKnife System when used to ablate localized prostate cancer in intermediate risk subjects with organ-confined prostate cancer. This study will evaluate the feasibility of the NanoKnife System as a focal therapy.

This study will involve six (6) subjects who meet the intermediate risk prostate cancer criteria defined by this protocol. The biopsy and imaging techniques that we will adopt within this trial are multiparametric MRI (mpMRI) and transperineal prostate biopsy (template mapping and/or limited targeted). The subjects' prostate cancer foci, the location of which will be determined by ultrasound guided transperineal prostate biopsy, will be targeted for treatment with the NanoKnife System. The primary objective of this the study will be to evaluate procedural and short-term post treatment safety of the NanoKnife treatment via incidence of adverse events and evaluation of effect on urologic (urinary and erectile) function. The secondary objective of this study is to evaluate the short term efficacy of the NanoKnife treatment. Local efficacy in the area of treatment will be assessed by histological evaluation of transperineal prostate biopsy cores at six (6) months post NanoKnife treatment, to evaluate the ablation zone created by the NanoKnife treatment. Other secondary outcomes include health-related quality of life levels evaluated using validated patient questionnaires. Following the 6 month transperineal prostate biopsy and mpMRI assessment, the data from these 6 subjects will be submitted to FDA for confirmation of short term safety and efficacy.

Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients

A Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in an Intermediate Risk Patient Population

To determine the NanoKnife treatment procedural and short-term post-treatment safety profile by evaluating adverse event incidence, type, duration, severity and relationship to study device.

To determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.

To determine completeness of ablation in the targeted prostate cancer tissue, in relation to probe placement and treatment parameters applied, as determined by histological evaluation of transperineal prostate biopsy cores at six (6) months post- treatment.

* Determine post-treatment PSA kinetics
* Determine effectiveness of therapy by post-treatment imaging (necrosis, presence of residual tissue)
* Determine effectiveness of therapy by rates of biochemical and clinical progression; need for secondary or adjuvant treatment

Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.

To determine the effectiveness of therapy by post-treatment early-contrast MRI and multiparametric magnetic resonance imaging (mpMRI) to evaluate the area of necrosis and presence of residual tissue.

To determine the effectiveness of therapy by recording the rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following therapy.

To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.

Angiodynamics, Inc.

Behaviors and Mental Disorders

Quality of Life

Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.

Focal High Intensity Focused Ultrasound (HIFU) treatment

Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance.

This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.

Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device

International Prostate Symptoms Score (IPSS) questionnaire

International Continence Society (ICS) questionnaire

International Index Erectile Function (IIEF-5) questionnaire

European Organization for Research and Treatment Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire

Hospices Civils de Lyon

Single arm. All Registered patients will undergo robotic surgery

Robotic Surgery after Focal Ablation Therapy

Robotic Surgery

Paul Cathcart

The toxicity of traditional prostate cancer therapies including radical surgery and external beam radiation is well known. This has prompted a move towards focal therapy where only the cancerous part of the prostate is treated.

To date, studies have demonstrated very promising outcomes following focal therapy with the majority of men maintaining their urinary and sexual function after therapy.

In a small proportion of men, disease recurs after focal therapy. The optimal treatment for men with recurrent disease after focal therapy is yet to be defined. Patients may undergo further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU) or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate is removed.

To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after focal therapy has not been formally studied.

Traditionally, the side effects of surgery and radiation therapy performed in patients that have already undergone previous prostate cancer treatment have been considerable with high rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a significant area of the prostate untreated, the investigators believe surgery after focal prostate therapy will be associated with a much lower incidence of urinary and sexual dysfunction.

The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in men that have undergone prior focal ablation therapy. In addition, the investigators wish to perform a number of basic science studies to attempt to better understand why the patient has experienced recurrent prostate cancer after focal therapy.

Robotic Surgery After Focal Ablation Therapy

This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed prior to surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.

This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed at 3-monthly intervals for 12 months following surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.

Will be quantified using Biochemical-free survival. Biochemical recurrence after surgery will be defined according to American Urological Association (AUA) guidance e.g. a post-surgical serum Prostate Specific Antigen (PSA) \>=0.2 on 2 separate occasions.

Will be quantified using need for androgen-ablation therapy. Androgen ablation therapy will include the commencement of Bicalutamide or Goserelin therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients	NCT01972867	Prostate Cancer	NanoKnife Proce...	18 Years -	Angiodynamics, Inc.
Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients	NCT01972867	Prostate Cancer	NanoKnife Proce...	18 Years -	Angiodynamics, Inc.
Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device	NCT02662673	Localized Prost...	Focal High Inte...	50 Years - 80 Years	Hospices Civils de Lyon
Robotic Surgery After Focal Ablation Therapy	NCT03011606	Prostate Cancer	Robotic Surgery	18 Years -	Queen Mary University of London
Robotic Surgery After Focal Ablation Therapy	NCT03011606	Prostate Cancer	Robotic Surgery	18 Years -	Queen Mary University of London

Spots Global Cancer Trial Database for focal

Every month we try and update this database with for focal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for focal

Every month we try and update this database with for focal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for focal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.