Prostate CancerNCT00573586
Treatment of Localized Prostate Cancer With High Intensity Focused Ultrasound Using the Sonablate® 500 System in Canada
A study testing Sonablate 500 (SB-500) in people with Prostate Cancer, run by SonaCare Medical at 1 site in Canada.
Trial summary
This is an investigational study on the use of high intensity focused ultrasound (HIFU) in the management of localized prostate cancer (T1c/T2a) as a primary non-comparative study. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sonablate 500 (SB-500)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2020to Dec 2020
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients with an initial presentation of organ confined prostate cancer;(clinical stages T1c and T2a only)
- Age 40 yrs. and older up to and including age 80 yrs.
- Anesthesia Surgical Assignment (ASA) categories I, II or III only
- PSA levels equal tyo or less than 10ng/ml
- Pre-HIFU Gleason score equal to or less than 7
- Clearly imageable prostate on TRUS
- Prostate total volume less than 40cc with an AP height less than or equal to 4.2cm. (If volume is greater than 40cc or height greater than 4.2 cm, one 3 monthly shot of an LHRH analogue may be provided, followed by re-imaging of the prostate to document total volume below 40cc.)
Who cannot join
- Large calcification in the area to be treated (>5mm)
- Bleeding disorder as determined by abnormal prothrombin time (INR) and partial thromboplastin time (PTT)
- Pt. on Coumadin or any other anticoagulent, unless their anticoagulation an be temporarily reversed or stopped
- Urinary tract infection unless treated satisfactorily by antibiotics and documented by a sterile urine culture
- Interest in future fertility
- History of allergy to latex
Show all 14Show fewer
- Inability to visualize the prostate tissue adequately on transrectal ultrasound imaging
- History of treatment for prostate cancer (except for one LHRH analogue "shrinkage shot")
- History of TURP, thermotherapy or urethral stent
- History of any major rectal surgery
- History of inflammatory bowel disease
- History of urinary bladder neck contracture
- History of any other malignancy other than skin cancer. Patients that have had a previous malignancy and no recurrence of that malignancy within the past 5 years will be allowed; (superficial bladder cancer is OK of clear for 2 years)
- Inability to be placed in lithotomy position Prior long term hormonal therapy for prostate cancer (including bilateral orchiectomy).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Abbotsford Regional Hospital Cancer Center
Abbotsford British Columbia, British Columbia
George Vrabec, MD
About this study
Official title: Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate® 500 (SB-500) System in Canada
This is an investigational study on the use of high intensity focused ultrasound (HIFU) in the management of localized prostate cancer (T1c/T2a) as a primary non-comparative study.
High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that uses intersecting, precision focused ultrasound waves to raise the temperature of the target to) 80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The tissue targeting is highly precise, minimizing collateral damage.
Read more
The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed with localized T1c/T2a prostate cancer, with minimal morbidity.
The specific hypothesis is that the Sonablate has the ability to:
- Completely destroy prostate cancer tissue, without causing damage to the intervening tissue, with a drop in PSA levels to <0.5ng/ml.
- Result in negative biopsies for evidence of viable malignant cells after the treatment (12 months if Nadir is not reached or PSA rises from Nadir)
- Safely treat localized prostate cancer patients, with minimal and acceptable adverse effects
- Conditions
- Prostate Cancer
- Being tested
- Sonablate 500 (SB-500)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonablate 500 (SB-500)Device
Sonablate 500 (SB-500)
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Other | Completely destroy prostate cancer tissue, without causing damage to the intervening tissue, with a drop in PSA levels to <0.5ng/ml.
* Result in negative biopsies for evidence of viable malignant cells after the treatment (12 months if Nadir is not reached or PSA rises from Nadir)
* Safely treat localized prostate cancer patients, with minimal and acceptable adverse effects Receives: Device: Sonablate 500 (SB-500) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA level
Measured: PSA level at 30 and 90 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startDec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SonaCare Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Vrabec, MD, Principal investigator, Abbotsford Regional Hospital Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573586
- Sponsor's protocol ID
- USHIFU-CABC-PC002
- Status last verified
- May 2019
- First submitted
- 12 Dec 2007
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate® 500 (SB-500) System in Canada
- ClinicalTrials.gov ID
- NCT00573586
- Acronym / sponsor ID
- USHIFU-CABC-PC002
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SonaCare MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Dec 2007 (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.
This is an investigational study on the use of high intensity focused ultrasound (HIFU) in the management of localized prostate cancer (T1c/T2a) as a primary non-comparative study.
High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that uses intersecting, precision focused ultrasound waves to raise the temperature of the target to) 80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The tissue targeting is highly precise, minimizing collateral damage.
The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed with localized T1c/T2a prostate cancer, with minimal morbidity.
The specific hypothesis is that the Sonablate has the ability to:
- Completely destroy prostate cancer tissue, without causing damage to the intervening tissue, with a drop in PSA levels to <0.5ng/ml.
- Result in negative biopsies for evidence of viable malignant cells after the treatment (12 months if Nadir is not reached or PSA rises from Nadir)
- Safely treat localized prostate cancer patients, with minimal and acceptable adverse effects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU | Other | Device: Sonablate 500 (SB-500)Completely destroy prostate cancer tissue, without causing damage to the intervening tissue, with a drop in PSA levels to <0.5ng/ml. * Result in negative biopsies for evidence of viable malignant cells after the treatment (12 months if Nadir is not reached or PSA rises from Nadir) * Safely treat localized prostate cancer patients, with minimal and acceptable adverse effects |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients with an initial presentation of organ confined prostate cancer;(clinical stages T1c and T2a only)
- Age 40 yrs. and older up to and including age 80 yrs.
- Anesthesia Surgical Assignment (ASA) categories I, II or III only
- PSA levels equal tyo or less than 10ng/ml
- Pre-HIFU Gleason score equal to or less than 7
Key exclusion criteria (14 listed)
- Large calcification in the area to be treated (>5mm)
- Bleeding disorder as determined by abnormal prothrombin time (INR) and partial thromboplastin time (PTT)
- Pt. on Coumadin or any other anticoagulent, unless their anticoagulation an be temporarily reversed or stopped
- Urinary tract infection unless treated satisfactorily by antibiotics and documented by a sterile urine culture
- Interest in future fertility
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 |
|---|---|---|
| Sonablate 500 (SB-500)Sonablate 500 (SB-500) | Device | HIFU |
Primary outcome
PSA level
Time frame: PSA level at 30 and 90 days post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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.
George Vrabec, MD principal investigator
Abbotsford Regional Hospital Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonablate 500 (SB-500) in people with Prostate Cancer, run by SonaCare Medical at 1 site in Canada.
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 7 inclusion and 14 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 3 May 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Vrabec, MD (604-587-4628, gvrabec@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA level (time frame: PSA level at 30 and 90 days 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 3 May 2019.