Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Chris Brew-Graves
ORCID ID
Contact details
Clinical Trials Group
Division of Surgery & Interventional Science
Faculty of Medical Sciences
University College London
Charles Bell House 67-73 Riding House Street
London
W1W 7EJ
United Kingdom
-
c.brew-graves@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02033447
Protocol/serial number
15516
Study information
Scientific title
MAGnetic NAnoparticle thermoaBLATion - retention and maintenance in prostatE: a Phase 0 study in men (MAGNABLATE I trial)
Acronym
MAGNABLATE I
Study hypothesis
This Phase 0 dose escalation safety trial aims to evaluate the retention of magnetic nanoparticles in the prostate.
The primary study objectives are:-
1. To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to cystoprostatectomy.
2. To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to prostatectomy.
3. To evaluate ex-vivo prostates with a special marker to determine the retention and distribution of the magnetic nanoparticles in relation to the intended target area at time of injection.
The secondary study objectives are:-
To evaluate the anatomical distribution of magnetic nanoparticles compared with injection site in prostate assessed by both Perls staining and postoperative imaging (MRI and CT) of the ex vivo tissue.
Ethics approval
First MREC approval date 17/09/2013, ref: 13/LO/1233
Study design
Non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate
Intervention
The trialists are aiming for a minimum of 60% of injected nanoparticles to be retained within the prostate over an average of first 6 patients. They aim to recruit a representative group of men who have overt cancer lesions as well as overt benign areas for injection.
They are aiming for the following:
Minimum number of benign prostate lobes 12
Minimum number of malignant lobes 6
Men undergoing Radical Cystoprostatectomy and Radical Prostatectomy will be recruited until the above numbers are fullfilled.
Injection of nano-particles, Pre-operative preparation: This procedure will be carried out just prior to the surgery (cystoprostatectomy or prostatectomy). The patient will be admitted on the morning of the procedure. The patient will be asked to sign the hospital procedure specific consent form.
Procedure set-up: Intravenous antibiotics (Gentamicin 120mg and Cefuroxime 1.5gm) are given just prior to injection unless contra-indicated.
The injection will be administered under general anaesthetic.
Surgery, Removal of prostate during radical cystoprostatectomy or radical prostatectomy surgery
Post-procedure care: The patient is discharged home once he has recovered from his major surgery as per standard of care. A contact number is given to the patient to call if any problems are encountered.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Rate of serious and other adverse events; Timepoint(s): For the duration the patient is in the study
Secondary outcome measures
1. Anatomical distribution of magnetic nanoparticles compared with injection site in prostate; Timepoint(s): On removal of the prostate
2. Percentage microsphere retention using Perl staining on whole-mount histology; Timepoint(s): At removal of the prostate
Overall trial start date
04/12/2013
Overall trial end date
03/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men undergoing:
1.1. Radical cystoprostatectomy for bladder cancer, or
1.2. Radical prostatectomy for prostate cancer
2. Men able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 18; UK Sample Size: 18
Participant exclusion criteria
1. Have taken any form of hormones (except 5alpha
reductase inhibitors) within the last 6 months
2. Unable to have MRI scan or CT scan, or in whom artefact would reduce scan quality
3. Unable to have general or regional anaesthesia
4. Men on immunosuppression or predefined immunosuppressed state
5. Men with a coagulopathy predisposing to bleeding to clot formation
6. Men with an inherited or acquired condition limiting metabolism of iron
7. Unable to give informed consent
Recruitment start date
04/12/2013
Recruitment end date
03/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
W1W 7EJ
United Kingdom
Funders
Funder type
Government
Funder name
NIHR (UK) - Central Commissioning Facility
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
09/08/2019
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list