Prostatic NeoplasmsNCT02341677
SmartTarget: BIOPSY
A study testing SmartTarget - Biopsy in people with Prostatic Neoplasms and Diagnostic Techniques and Procedures, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer. The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms, Diagnostic Techniques and Procedures
- What is being tested?
- SmartTarget - Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Sep 2016
- 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
- Previous TRUS biopsy with clinical indication for repeat biopsy
- Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale
- 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
- Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
- Men with an irreversible coagulopathy predisposing to bleeding
- Men who are unability to undergo transrectal ultrasonography
- Men who have had previous radiation therapy to the pelvis
- Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
- Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- Men who are unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy
The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.
The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.
Read more
An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.
SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.
This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget
- Being tested
- SmartTarget - Biopsy
- Keywords
- Prostatic Neoplasms, Diagnostic Techniques and Procedures, Magnetic Resonance Imaging, Ultrasonography, Biopsy, 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 - BiopsyProcedure or surgery
MRI to ultrasound fusion guided prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Biopsy | Experimental | Single Arm Study. Biopsy Intervention. Receives: Procedure: SmartTarget - Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection
The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.
Measured: Within 3 weeks of biopsy
Secondary outcomes (3)
Targeting Efficiency (core length, grade)
The targeting efficiency of the SmartTarget guided biopsies versus visually-directed biopsies measured by:
Number of cores required to obtain the highest cancer risk category Number of cores with cancer Maximum Cancer Core Length and Total Cancer Core Length Highest Grade Cancer
Measured: Within 3 weeks of Biopsy
Clinical Usability (length of procedure, generation time, re-registration rate, failure rate)
To evaluate the clinical usability of SmartTarget guided biopsy as measured by:
Length of Procedure SmartTarget model generation time SmartTarget re-registration rate SmartTarget failure rate
Measured: During Procedure
Quality of Life
To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires:
IPSS IIEF EQ5D - 5L
Measured: 6 Weeks post biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2016
- Study completionSep 2016
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
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
- NCT02341677
- Sponsor's protocol ID
- 14/0044
- Status last verified
- Jan 2019
- First submitted
- 24 Nov 2014
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. 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: Biopsy
- ClinicalTrials.gov ID
- NCT02341677
- Acronym / sponsor ID
- 14/0044
- Keywords
- Prostatic Neoplasms, Diagnostic Techniques and Procedures, Magnetic Resonance Imaging, Ultrasonography, Biopsy, Image Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Jan 2015 (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 determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.
The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.
An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.
SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.
This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy | Experimental | Procedure: SmartTarget - BiopsySingle Arm Study. Biopsy Intervention. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Previous TRUS biopsy with clinical indication for repeat biopsy
- Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
- Signed informed consent
Key exclusion criteria (7 listed)
- Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
- Men with an irreversible coagulopathy predisposing to bleeding
- Men who are unability to undergo transrectal ultrasonography
- Men who have had previous radiation therapy to the pelvis
- Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
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 - BiopsyMRI to ultrasound fusion guided prostate biopsy | Procedure or surgery | Biopsy |
Primary outcome
Cancer Detection
Time frame: Within 3 weeks of biopsy
The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.
3 secondary outcomes
Targeting Efficiency (core length, grade)
Time frame: Within 3 weeks of Biopsy
Clinical Usability (length of procedure, generation time, re-registration rate, failure rate)
Time frame: During Procedure
Quality of Life
Time frame: 6 Weeks post biopsy
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 31 Jan 2019.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartTarget - Biopsy in people with Prostatic Neoplasms and Diagnostic Techniques and Procedures, run by University College, London 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 4 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 31 Jan 2019. 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.
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?
Cancer Detection (time frame: Within 3 weeks of biopsy). 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 31 Jan 2019.