Prostate CancerPhase 2/3NCT02016040
Focal Therapy Using HIFU for Localised Prostate Cancer
A Phase 2/3 study testing High Intensity Focused Ultrasound in people with Prostate Cancer, run by Jewish General Hospital at 1 site in Canada.
Trial summary
To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®). Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High Intensity Focused Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2013to Nov 2017
- Phase
- Phase 2/3
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 50 years
- Clinical stage T1c (normal digital rectal examination) or T2a (one palpable nodule on digital rectal examination)
- PSA ≤10 ng / mL
- Presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex).
- Gleason score ≤ 7 (3+4)
- Flowmetry > 12 mL / sec for a voided volume of 125 mL
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- PVR <100 mL
- Patient with normal anal and rectal anatomy.
- Patient with a condition corresponding to a classification of ASA 1 or 2.
- Patient signing ICF and agreed for following monitoring
Who cannot join
- Patient with an ASA score 3.
- Patient in clinical stage T1a, T1b, T2b, T2c or T3.
- Patient with a tumor visible on MRI: Located at a distance less than 5 mm from the midline. Located less than 6 mm from the apex real
- Metastatic lymph node or metastasis discovered by MRI and bone scan.
- Patient previously treated for his prostate cancer by hormone therapy.
- Patient with a distance between the rectal mucosa and prostate capsule over 8 mm thick
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- History of inflammatory bowel disease
- Rectal fistula.
- History of pelvic radiotherapy.
- History of bladder cancer.
- History of bladder neck sclerosis or urethral stenosis.
- Patient with an implant located less than 1 cm from the treatment zone (stent, catheter).
- Urogenital infection.
- Latex allergy
- Contraindication to MRI (pacemaker,metal prosthesis ...)
- Patient participated in another clinical study within 30 days.
- Illiterate patients
- Legally incapable patients
Trial locations and contacts
1 site in 1 country.
Canada1 site
Jewish General Hospital,Urology Department
Montreal, Quebec, H3T 1E2
About this study
Official title: Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer
To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®).
Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment.
A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.
- Conditions
- Prostate Cancer
- Being tested
- High Intensity Focused Ultrasound
- Keywords
- Prostate cancer, HIFU Hemi-ablation, Prostate biopsies
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused UltrasoundProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HIFU hemi-ablation | Active comparator | Focal Therapy Using High Intensity Focused Ultrasound (Ablatherm) Receives: Procedure: High Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients without cancer
MRI,Biopsy,PSA
Measured: Six months
Secondary outcomes (3)
Immediate tolerance of hemi-ablation
Adverse events
Measured: One year
Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life
Questionnaires
Measured: One year
Cost of hemi-ablation HIFU treatment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start17 Mar 2013
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Franck Bladou, Jewish General Hospital
- Investigators
- Franck Bladou, MD, Principal investigator, Jewish General Hospital,Urology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016040
- Sponsor's protocol ID
- #12-030
- Status last verified
- Apr 2017
- First submitted
- 3 Dec 2013
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer
- ClinicalTrials.gov ID
- NCT02016040
- Acronym / sponsor ID
- #12-030
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, HIFU Hemi-ablation, Prostate biopsies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 17 Mar 2013 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 19 Dec 2013 (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.
To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®).
Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment.
A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU hemi-ablation | Active comparator | Procedure: High Intensity Focused UltrasoundFocal Therapy Using High Intensity Focused Ultrasound (Ablatherm) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age≥ 50 years
- Clinical stage T1c (normal digital rectal examination) or T2a (one palpable nodule on digital rectal examination)
- PSA ≤10 ng / mL
- Presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex).
- Gleason score ≤ 7 (3+4)
Key exclusion criteria (18 listed)
- Patient with an ASA score 3.
- Patient in clinical stage T1a, T1b, T2b, T2c or T3.
- Patient with a tumor visible on MRI: Located at a distance less than 5 mm from the midline. Located less than 6 mm from the apex real
- Metastatic lymph node or metastasis discovered by MRI and bone scan.
- Patient previously treated for his prostate cancer by hormone therapy.
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 |
|---|---|---|
| High Intensity Focused Ultrasound | Procedure or surgery | HIFU hemi-ablation |
Primary outcome
Rate of patients without cancer
Time frame: Six months
MRI,Biopsy,PSA
3 secondary outcomes
Immediate tolerance of hemi-ablation
Time frame: One year
Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life
Time frame: One year
Cost of hemi-ablation HIFU treatment
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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.
Franck Bladou, MD principal investigator
Jewish General Hospital,Urology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing High Intensity Focused Ultrasound in people with Prostate Cancer, run by Jewish General Hospital 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 10 inclusion and 18 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 19 Apr 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Rate of patients without cancer (time frame: Six months). 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 19 Apr 2017.