Prostate CancerPhase 1NCT01522118
MR-guided Focused Ultrasound Treatment of Prostate Cancer: Focal Therapy for Locally Non-Advanced Disease
A Phase 1 study testing ExAblate 2100; InSightec in people with Prostate Cancer, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Since prostate specific antigen (PSA) was introduced as a clinical screening tool for prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced disease. The present choice of treatment for men with localized prostate cancer lies between active surveillance and radical therapy. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ExAblate 2100; InSightec
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Jun 2012
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of age between 40 to 85
- Patient with organ-confined Pca (cT1c and cT2a, N0, M0), diagnosed with TRUS biopsy (min:12 cores)
- Patient with PSA ≤ 10 ng/mL
- Gleason score 6 (3+3) or max 7 (3+4)
- Up to two (2) MR identifiable lesions
- No definite evidence of extracapsular extension
Who cannot join
- Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
- Any rectal pathology, anomaly or previous treatment
- Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall
- Bladder cancer
- Seminal vesicle/lymph node
- Prostate with multiple cystic lesions
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Radiological Sciences, Sapienza University of Rome
Rome, 00100
About this study
Official title: Focal Therapy With Magnetic Resonance Guided Focused Ultrasound Treatment of Locally Non-Advanced Prostate Cancer: Phase 1 Study
Since prostate specific antigen (PSA) was introduced as a clinical screening tool for prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced disease. The present choice of treatment for men with localized prostate cancer lies between active surveillance and radical therapy. Thus, the option of treating only the cancer within the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very controversial. At present there are no consistent scientific data on focal therapy and its major effectiveness.
Focal therapy for prostate cancer is defined as therapy that selectively ablates known disease while preserving existing functions, with the overall aim of minimizing lifetime morbidity without compromising life expectancy.
Read more
The aim of the investigators study is to test if Magnetic Resonance guided Focused Ultrasound ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer.
The study i designed as Phase 1, treatment \& resection protocol. With this project the investigators further aim to evaluate the safety and identify side effects of Magnetic Resonance guided Focused Ultrasound in treating focal prostate cancer.
This design will also expand knowledge of the effect of Magnetic Resonance guided Focused Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted after this non-invasive treatment.
- Conditions
- Prostate Cancer
- Being tested
- ExAblate 2100; InSightec
- Keywords
- Prostate Cancer, High Intensity Focused Ultrasound, Magnetic Resonance guided Focused Ultrasound, Non-invasive therapy, Focal Disease
- 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 2100; InSightecDevice
Patients with biopsy proven locally non-advanced T2 prostate cancer identified at 3T MR examination including dynamic contrast enhanced (DCE-with time to peak and mean transit time evaluation) and candidate to radical prostatectomy will undergo Magnetic Resonance guided Focused Ultrasound (MRgFUS) ablation. The procedure is carried out either under general anesthesia or spinal block.
MR images allow correct identification of the target as well as vital structure to avoid during energy delivery. Treatment safety and efficacy is monitored in real time using MR thermometry. Adjustments of energy direction and intensity can be made according to the real time monitoring. Pre- and post-ablative MR examinations will serve to analyze differences of DCE features of the neoplastic tissue; therapy-induced alterations will also be compared to histopathology findings from whole section prostate specimens
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Experimental | (high intensity focused ultrasound) Receives: Device: ExAblate 2100; InSightec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measure of expected or UN-expected adverse events
Measured: One year
Secondary outcomes (1)
Efficacy
Measure of ablated area in terms of necrosis vs residual tumor
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionJun 2012
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 University of Roma La SapienzaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Napoli, University of Roma La Sapienza
- Investigators
- alessandro napoli, MD, PhD, Principal investigator, Department of Radiological Sciences, Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522118
- Sponsor's protocol ID
- PCa-MRgFUS-I
- Status last verified
- Feb 2013
- First submitted
- 23 Jan 2012
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Therapy With Magnetic Resonance Guided Focused Ultrasound Treatment of Locally Non-Advanced Prostate Cancer: Phase 1 Study
- ClinicalTrials.gov ID
- NCT01522118
- Acronym / sponsor ID
- PCa-MRgFUS-I
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, High Intensity Focused Ultrasound, Magnetic Resonance guided Focused Ultrasound, Non-invasive therapy, Focal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Jan 2012 (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.
Since prostate specific antigen (PSA) was introduced as a clinical screening tool for prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced disease. The present choice of treatment for men with localized prostate cancer lies between active surveillance and radical therapy. Thus, the option of treating only the cancer within the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very controversial. At present there are no consistent scientific data on focal therapy and its major effectiveness.
Focal therapy for prostate cancer is defined as therapy that selectively ablates known disease while preserving existing functions, with the overall aim of minimizing lifetime morbidity without compromising life expectancy.
The aim of the investigators study is to test if Magnetic Resonance guided Focused Ultrasound ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer.
The study i designed as Phase 1, treatment \& resection protocol. With this project the investigators further aim to evaluate the safety and identify side effects of Magnetic Resonance guided Focused Ultrasound in treating focal prostate cancer.
This design will also expand knowledge of the effect of Magnetic Resonance guided Focused Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted after this non-invasive treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU | Experimental | Device: ExAblate 2100; InSightec(high intensity focused ultrasound) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of age between 40 to 85
- Patient with organ-confined Pca (cT1c and cT2a, N0, M0), diagnosed with TRUS biopsy (min:12 cores)
- Patient with PSA ≤ 10 ng/mL
- Gleason score 6 (3+3) or max 7 (3+4)
- Up to two (2) MR identifiable lesions
Key exclusion criteria (6 listed)
- Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
- Any rectal pathology, anomaly or previous treatment
- Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall
- Bladder cancer
- Seminal vesicle/lymph node
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 2100; InSightecPatients with biopsy proven locally non-advanced T2 prostate cancer identified at 3T MR examination including dynamic contrast enhanced (DCE-with time to peak and mean transit time evaluation) and candidate to radical prostatectomy will undergo Magnetic Resonance guided Focused Ultrasound (MRgFUS) ablation. The procedure is carried out either under general anesthesia or spinal block. MR images allow correct identification of the target as well as vital structure to avoid during energy delivery. Treatment safety and efficacy is monitored in real time using MR thermometry. Adjustments of energy direction and intensity can be made according to the real time monitoring. Pre- and post-ablative MR examinations will serve to analyze differences of DCE features of the neoplastic tissue; therapy-induced alterations will also be compared to histopathology findings from whole section prostate specimens | Device | HIFU |
Primary outcome
Safety
Time frame: One year
Measure of expected or UN-expected adverse events
1 secondary outcome
Efficacy
Time frame: 18 months
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 26 Feb 2013.
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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.
alessandro napoli, MD, PhD principal investigator
Department of Radiological Sciences, Sapienza University of Rome
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 2100; InSightec in people with Prostate Cancer, run by University of Roma La Sapienza at 1 site in Italy.
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 6 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 26 Feb 2013. 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 Italy. 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?
Safety (time frame: One year). 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 26 Feb 2013.