Prostate CancerNCT00537849
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
A study testing Sonablate 500(SB-500) in people with Prostate Cancer, run by SonaCare Medical at 1 site in Canada.
Trial summary
An investigational study on the use of HIFU in the management of localized prostate cancer 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… 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
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Mar 2008
- 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 15Show 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.
About this study
An investigational study on the use of HIFU in the management of localized prostate cancer 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 pts., 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
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 posted1 Oct 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2008 (estimated)
- Study completionMar 2008 (estimated)
Why it stopped: Sponsor withdrew request to conduct study
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SonaCare Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan I So, MD, Principal investigator, The Prostate Centre at Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537849
- Sponsor's protocol ID
- HIFU-PC-002
- Status last verified
- Apr 2019
- First submitted
- 27 Sep 2007
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 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
- NCT00537849
- Acronym / sponsor ID
- HIFU-PC-002
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrew request to conduct study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SonaCare MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 1 Oct 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.
An investigational study on the use of HIFU in the management of localized prostate cancer 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 pts., with minimal and acceptable adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 (15 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) | Device | – |
Primary outcome
PSA level
Time frame: PSA level at 30 and 90 days post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Alan I So, MD principal investigator
The Prostate Centre at Vancouver General Hospital
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 15 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: withdrawn, as of the sponsor's last update on 10 Apr 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
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 10 Apr 2019.