Prostate CancerPhase 1NCT00811265
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
A Phase 1 study testing ExAblate MRgFUS for prostate cancer in people with Prostate Cancer, run by InSightec at 1 site in Israel.
Trial summary
Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ExAblate MRgFUS for prostate cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jun 2013
- Phase
- 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 Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age of patients: up to 75 years.
- Men scheduled for radical prostatectomy due to prostate cancer.
- Patients who are able and willing to give consent and able to attend all study visits.
Who cannot join
- Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
- Severely abnormal coagulation (INR>1.5)
- Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.)
- Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc…)
- Any spinal pathology that prohibits maintaining supine position for more then an hour
- Any previous radiation to the pelvis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer
Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
Read the detailed description
The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.
- Conditions
- Prostate Cancer
- Being tested
- ExAblate MRgFUS for prostate cancer
- Keywords
- ExAblate MRgFUS, Focused ultrasound, Magnetic resonance imaging, Prostate cancer, Radical prostatectomy candidate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate MRgFUS for prostate cancerDevice
Simulated use of ExAblate MRgFUS system
| Study group | Role | What they receive |
|---|---|---|
| Simulated ExAblate MRgFUS | Experimental | Patients undergoing simulated ExAblate MRgFUS device use Receives: Device: ExAblate MRgFUS for prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related adverse events
Measured: Throughout study period
Secondary outcomes (2)
Device compatibility with human anatomy
Measured: During simulated device use
MR Imaging Quality
Measured: During simulated device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2013
- Study completionJun 2013
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.
- More trials run by InSightecThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811265
- Sponsor's protocol ID
- PC001
- Status last verified
- Mar 2016
- First submitted
- 17 Dec 2008
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00811265
- Acronym / sponsor ID
- PC001
- Conditions
- Prostate Cancer
- Keywords
- ExAblate MRgFUS, Focused ultrasound, Magnetic resonance imaging, Prostate cancer, Radical prostatectomy candidate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Dec 2008 (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.
Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
Detailed description
The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulated ExAblate MRgFUS | Experimental | Device: ExAblate MRgFUS for prostate cancerPatients undergoing simulated ExAblate MRgFUS device use |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age of patients: up to 75 years.
- Men scheduled for radical prostatectomy due to prostate cancer.
- Patients who are able and willing to give consent and able to attend all study visits.
Key exclusion criteria (8 listed)
- Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
- Severely abnormal coagulation (INR>1.5)
- Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.)
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 |
|---|---|---|
| ExAblate MRgFUS for prostate cancerSimulated use of ExAblate MRgFUS system | Device | Simulated ExAblate MRgFUS |
Primary outcome
Device-related adverse events
Time frame: Throughout study period
2 secondary outcomes
Device compatibility with human anatomy
Time frame: During simulated device use
MR Imaging Quality
Time frame: During simulated device use
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 8 Mar 2016.
- Web page of clinical study SponsorLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ExAblate MRgFUS for prostate cancer in people with Prostate Cancer, run by InSightec at 1 site in Israel.
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 8 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 8 Mar 2016. 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 Israel. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Device-related adverse events (time frame: Throughout study period). 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 8 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.