Prostatic NeoplasmsNCT02290561
SmartTarget THERAPY
A study testing SmartTarget Therapy, MRI and high intensity focused ultrasound (HIFU) in people with Prostatic Neoplasms, run by University College, London.
Trial summary
The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate. The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- SmartTarget Therapy, MRI and high intensity focused ultrasound (HIFU)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Oct 2015
- Phase
- Interventional
- 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
- Histological diagnosis of prostate cancer (PSA </=15ng/ml, Gleason score </=4+3, and radiological stage </=T3aNoMo)
- Prostate biopsy concordant with mpMRI lesion (template transperineal or MRI-targeted biopsy only)
- Discrete lesion on mpMRI scoring 3, 4 or 5 on radiological scale of suspicion
- mpMRI carried out according to European Society of Uro-Radiology guidelines at 1.5T or 3T
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
- Signed informed consent
Who cannot join
- No lesion on mpMRI
- Bilateral lesions on mpMRI
- mpMRI undertaken over 6 months prior to visit 1
- Contralateral Gleason >/=3+4 and/or Maximum Cancer Core Length Involvement >/=6mm
- Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
- Prior immunosuppression or predefined immunosuppressed state
Show all 13Show fewer
- An irreversible coagulopathy predisposing to bleeding
- Unable to undergo transrectal ultrasonography
- Previous radiation therapy to the pelvis
- Previous HIFU, cryosurgery, thermal, irreversible electroporation, radiofrequency or microwave therapy to the prostate.
- Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- Men not fit for major surgery as assessed by a consultant anaesthetist
- Men who are unable to give informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy
The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.
The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue.
Read more
Prior to surgery prostate cancer can often be localised using MRI imaging and detailed prostate biopsy techniques. The difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause higher rates of side-effects.
SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the live ultrasound during surgery. It then provides a target for the surgeons to treat during the operation.
The results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan
- Conditions
- Prostatic Neoplasms
- Being tested
- SmartTarget Therapy, MRI, high intensity focused ultrasound (HIFU)
- Keywords
- Prostatic Neoplasms, Therapeutics, Magnetic Resonance Imaging, Ultrasonography, High Intensity Focused Ultrasound, Image Fusion
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartTarget TherapyProcedure or surgery
MRI to Ultrasound fusion directed HIFU
MRIDevice
high intensity focused ultrasound (HIFU)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Ablation
The ability of SmartTarget-directed focal HIFU therapy to ablate an intended target within the prostate, as measured by the proportion of men in whom complete ablation of the target region is achieved. Complete or incomplete ablation is determined by a comparative assessment of the pre-therapy and one week post-therapy contrast-enhanced MRIs by an expert radiologist.
Measured: 1 week post treatment
Secondary outcomes (3)
Accuracy
The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one week post treatment.
Measured: 1 week post treatment
Length of the procedure
The efficiency and clinical usability of the SmartTarget device as measured by the:
Length of the procedure
The time taken during the procedure using SmartTarget, including:
The total prostate computer model generation time The total time taken to register (fuse) MRI and ultrasound image data and the number of times an image registration is performed using SmartTarget (the re-registration rate) SmartTarget failure rate
Measured: intraoperative
Quality of Life
To assess how this treqatment strategy impacts on quality of life as measured using validated questionnaires at 6 weeks and 3 months post treatment.
IPSS IIEF EQ5D - 5L
Measured: 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hashim U Ahmed, FRCS PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290561
- Sponsor's protocol ID
- 14/0389
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy
- ClinicalTrials.gov ID
- NCT02290561
- Acronym / sponsor ID
- 14/0389
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatic Neoplasms, Therapeutics, Magnetic Resonance Imaging, Ultrasonography, High Intensity Focused Ultrasound, Image Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 14 Nov 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.
The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.
The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue.
Prior to surgery prostate cancer can often be localised using MRI imaging and detailed prostate biopsy techniques. The difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause higher rates of side-effects.
SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the live ultrasound during surgery. It then provides a target for the surgeons to treat during the operation.
The results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Histological diagnosis of prostate cancer (PSA </=15ng/ml, Gleason score </=4+3, and radiological stage </=T3aNoMo)
- Prostate biopsy concordant with mpMRI lesion (template transperineal or MRI-targeted biopsy only)
- Discrete lesion on mpMRI scoring 3, 4 or 5 on radiological scale of suspicion
- mpMRI carried out according to European Society of Uro-Radiology guidelines at 1.5T or 3T
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
Key exclusion criteria (13 listed)
- No lesion on mpMRI
- Bilateral lesions on mpMRI
- mpMRI undertaken over 6 months prior to visit 1
- Contralateral Gleason >/=3+4 and/or Maximum Cancer Core Length Involvement >/=6mm
- Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
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 |
|---|---|---|
| SmartTarget TherapyMRI to Ultrasound fusion directed HIFU | Procedure or surgery | – |
| MRI | Device | – |
| high intensity focused ultrasound (HIFU) | Device | – |
Primary outcome
Target Ablation
Time frame: 1 week post treatment
The ability of SmartTarget-directed focal HIFU therapy to ablate an intended target within the prostate, as measured by the proportion of men in whom complete ablation of the target region is achieved. Complete or incomplete ablation is determined by a comparative assessment of the pre-therapy and one week post-therapy contrast-enhanced MRIs by an expert radiologist.
3 secondary outcomes
Accuracy
Time frame: 1 week post treatment
Length of the procedure
Time frame: intraoperative
Quality of Life
Time frame: 6 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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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 U Ahmed, FRCS PhD principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
A study testing SmartTarget Therapy, MRI and high intensity focused ultrasound (HIFU) in people with Prostatic Neoplasms, run by University College, London.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian A Donaldson, BMBS MRCS (0044 (0)207 679 9092, i.donaldson@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Ablation (time frame: 1 week post treatment). 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 14 Nov 2014.