Prostate CancerEarly Phase 1MAGNABLATE INCT02033447
Magnetic Nanoparticle Thermoablation-Retention and Maintenance in the Prostate:A Phase 0 Study in Men
A Early Phase 1 study testing Magnetic Nanoparticle Injection in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
Men with early prostate cancer face a number of options which lie at the extremes of care. On one hand, active surveillance involves monitoring the disease and on the other, immediate treatment involves surgery or radiotherapy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Magnetic Nanoparticle Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Jan 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing radical cystoprostatectomy for bladder cancer
- Patients undergoing radical prostatectomy for prostate cancer
- Patients giving informed consent
Who cannot join
- Have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
- Unable to have MRI scan or CT scan, or in whom artefact would reduce scan quality
- Unable to have general or regional anaesthesia
- Patients on immunosuppression or predefined immunosuppressed state
- Patients with a coagulopathy predisposing to bleeding to clot formation
- Patients with an inherited or acquired condition limiting metabolism of iron
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NW1 2BU
About this study
Men with early prostate cancer face a number of options which lie at the extremes of care. On one hand, active surveillance involves monitoring the disease and on the other, immediate treatment involves surgery or radiotherapy. The difference between these two strategies in terms of reducing the chance of a man dying from his disease is small. Not only is the benefit small, surgery or radiotherapy carry significant side-effects. These occur because of damage to surrounding tissue resulting in incontinence of urine (1 in 5), erectile dysfunction (1 in 2) and back-passage bleeding, diarrhoea or discomfort (1 in 10).
The investigators have been working on new forms of treatment that use heat, light or cold to destroy tissue and minimise treatment-related harms. The investigators have not yet found one that delivers the ideal treatment. The ideal treatment is one that can be done under local anaesthetic, can effectively destroy areas of cancer, limit damage to surrounding tissues, is repeatable, and adaptable to future discoveries such as molecular targeting of cancer cells.
Read more
The investigators think magnetic thermoablation may be able to deliver on these ideal attributes. Magnetic thermoablation involves injecting magnetic iron nanoparticles directly into the cancer. When a magnetic field is applied close to them, these nanoparticles heat up to very high temperatures that kill cells. Magnetic thermoablation does not use x-rays or surgical incisions. The investigators have done a lot of the preclinical work already to develop this type of treatment. The investigators now need to develop a system that can be used to treat prostate cancer. However, before the investigators can do this, they need to test whether the magnetic nanoparticles actually stay where they are injected. The consequences of them moving to areas that they should not can be serious. First, the nanoparticles could move away from the cancer which means the cancer will not be heated effectively. Second, the nanoparticles could move to sensitive structures around the prostate (back-passage, bladder, sphincter muscle controlling urine flow, nerves controlling erections). If this happens, damage of those sensitive structures could occur leading to side-effects.
The investigators propose a study to try and find out what happens to those nanoparticles. The study will involve approaching men who are having their prostates removed by radical surgery. If these patients agree to participate, the investigators will inject their prostate with varying amounts of nanoparticles. The investigators will NOT heat them up. The investigators will use special scans and, once they have had their surgery, to look at the pathology specimens to see where the nanoparticles have gone. The actual nanoparticles are not harmful but the process of injection can carry a small amount of harm. If the nanoparticles stay where they are injected, the investigators will then be able to run another study in which we treat men who have prostate cancer with magnetic thermoablation.
Read the detailed description
PRIMARY
1.1 To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to cystoprostatectomy. 1.2 To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to prostatectomy. 1.3 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
SECONDARY 2.1 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
- Conditions
- Prostate Cancer
- Being tested
- Magnetic Nanoparticle Injection
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Nanoparticle InjectionOther
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Nanoparticle Injection | Experimental | Patients undergoing radical cystoprostatectomy or prostatectomy Receives: Other: Magnetic Nanoparticle Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
1.1 dose escalation safety trial of magnetic nanoparticles injected into the prostates of patients prior to cystoprostatectomy.
1.2 a dose escalation safety trial of magnetic nanoparticles injected into the prostates of patients prior to prostatectomy.
1.3 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
Measured: outcome measures assessed every month and presented at 12 months for the primary end points
Secondary outcomes (1)
The anatomical distribution of magnetic nanoparticles
2.1 anatomical distribution of magnetic nanoparticles compared with injection site in prostate assessed by both Perls' staining and postoperative imaging (MRIand CT) of the ex vivo tissue
Measured: every month will be assessed and presented at 12 months for the secondary end points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Uddin Ahmed, University College London Hospitals
- Investigators
- Hashim Ahmed, MbChB, PhD, Principal investigator, MRC Clinical Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033447
- Sponsor's protocol ID
- 13/0257
- Other IDs
- National Institute for Health
- Acronym
- MAGNABLATE I
- Status last verified
- May 2017
- First submitted
- 6 Jan 2014
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Nanoparticle Thermoablation-Retention and Maintenance in the Prostate:A Phase 0 Study in Men
- ClinicalTrials.gov ID
- NCT02033447
- Acronym / sponsor ID
- MAGNABLATE I / 13/0257
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Men with early prostate cancer face a number of options which lie at the extremes of care. On one hand, active surveillance involves monitoring the disease and on the other, immediate treatment involves surgery or radiotherapy. The difference between these two strategies in terms of reducing the chance of a man dying from his disease is small. Not only is the benefit small, surgery or radiotherapy carry significant side-effects. These occur because of damage to surrounding tissue resulting in incontinence of urine (1 in 5), erectile dysfunction (1 in 2) and back-passage bleeding, diarrhoea or discomfort (1 in 10).
The investigators have been working on new forms of treatment that use heat, light or cold to destroy tissue and minimise treatment-related harms. The investigators have not yet found one that delivers the ideal treatment. The ideal treatment is one that can be done under local anaesthetic, can effectively destroy areas of cancer, limit damage to surrounding tissues, is repeatable, and adaptable to future discoveries such as molecular targeting of cancer cells.
The investigators think magnetic thermoablation may be able to deliver on these ideal attributes. Magnetic thermoablation involves injecting magnetic iron nanoparticles directly into the cancer. When a magnetic field is applied close to them, these nanoparticles heat up to very high temperatures that kill cells. Magnetic thermoablation does not use x-rays or surgical incisions. The investigators have done a lot of the preclinical work already to develop this type of treatment. The investigators now need to develop a system that can be used to treat prostate cancer. However, before the investigators can do this, they need to test whether the magnetic nanoparticles actually stay where they are injected. The consequences of them moving to areas that they should not can be serious. First, the nanoparticles could move away from the cancer which means the cancer will not be heated effectively. Second, the nanoparticles could move to sensitive structures around the prostate (back-passage, bladder, sphincter muscle controlling urine flow, nerves controlling erections). If this happens, damage of those sensitive structures could occur leading to side-effects.
The investigators propose a study to try and find out what happens to those nanoparticles. The study will involve approaching men who are having their prostates removed by radical surgery. If these patients agree to participate, the investigators will inject their prostate with varying amounts of nanoparticles. The investigators will NOT heat them up. The investigators will use special scans and, once they have had their surgery, to look at the pathology specimens to see where the nanoparticles have gone. The actual nanoparticles are not harmful but the process of injection can carry a small amount of harm. If the nanoparticles stay where they are injected, the investigators will then be able to run another study in which we treat men who have prostate cancer with magnetic thermoablation.
Detailed description
PRIMARY
1.1 To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to cystoprostatectomy. 1.2 To conduct a dose escalation safety trial of magnetic nanoparticles injected into the prostates of men prior to prostatectomy. 1.3 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
SECONDARY 2.1 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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Nanoparticle Injection | Experimental | Other: Magnetic Nanoparticle InjectionPatients undergoing radical cystoprostatectomy or prostatectomy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing radical cystoprostatectomy for bladder cancer
- Patients undergoing radical prostatectomy for prostate cancer
- Patients giving informed consent
Key exclusion criteria (7 listed)
- Have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
- Unable to have MRI scan or CT scan, or in whom artefact would reduce scan quality
- Unable to have general or regional anaesthesia
- Patients on immunosuppression or predefined immunosuppressed state
- Patients with a coagulopathy predisposing to bleeding to clot formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Nanoparticle Injection | Other | Magnetic Nanoparticle Injection |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: outcome measures assessed every month and presented at 12 months for the primary end points
1.1 dose escalation safety trial of magnetic nanoparticles injected into the prostates of patients prior to cystoprostatectomy. 1.2 a dose escalation safety trial of magnetic nanoparticles injected into the prostates of patients prior to prostatectomy. 1.3 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
1 secondary outcome
The anatomical distribution of magnetic nanoparticles
Time frame: every month will be assessed and presented at 12 months for the secondary end points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashim Ahmed, MbChB, PhD principal investigator
MRC Clinical Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnetic Nanoparticle Injection in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: outcome measures assessed every month and presented at 12 months for the primary end points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.