Magnetic nanoparticle thermoablation - retention and maintenance in prostate

ISRCTN	ISRCTN96083641
DOI	https://doi.org/10.1186/ISRCTN96083641
ClinicalTrials.gov number	NCT02033447
Secondary identifying numbers	15516

Submission date: 17/12/2013
Registration date: 17/12/2013
Last edited: 09/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-nanoparticles-heat-destroy-prostate-cancer-magnablate-i-trial

Contact information

Ms Chris Brew-Graves
Scientific

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

Email	c.brew-graves@ucl.ac.uk

Study information

Study design	Non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	MAGnetic NAnoparticle thermoaBLATion - retention and maintenance in prostatE: a Phase 0 study in men (MAGNABLATE I trial)
Study acronym	MAGNABLATE I
Study objectives	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(s)	First MREC approval date 17/09/2013, ref: 13/LO/1233
Health condition(s) or problem(s) studied	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
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 study start date	04/12/2013
Completion date	03/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	Planned Sample Size: 18; UK Sample Size: 18
Key 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
Key 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
Date of first enrolment	04/12/2013
Date of final enrolment	03/12/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London

London
W1W 7EJ
United Kingdom

Sponsor information

University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

NIHR (UK) - Central Commissioning Facility

No information available

Results and Publications

Intention to publish date	09/08/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

09/08/2019: The following changes were made to the trial record:
1. ClinicalTrials.gov number added.
2. No publications found, verifying study status with principal investigator.
3. The intention to publish date was added.
13/03/2017: No publications found, verifying study status with principal investigator.

Magnetic nanoparticle thermoablation - retention and maintenance in prostate