Condition category
Cancer
Date applied
17/12/2013
Date assigned
17/12/2013
Last edited
19/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Protocol/serial number

15516

Study information

Scientific title

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.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15516

Ethics approval

13/LO/1233; First MREC approval date 17/09/2013

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate

Intervention

We are aiming for a minimum of 60% of injected nanoparticles to be retained within the prostate over an average of first 6 patients. We aim to recruit a representative group of men who have overt cancer lesions as well as overt benign areas for injection.
We 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 measures

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

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

Clinical Trials Group
London
W1W 7EJ
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes