Localized Prostate CancerIDITOP-3NCT02662673
Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device
A study testing Focal High Intensity Focused Ultrasound (HIFU) treatment in people with Localized Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Localized Prostate Cancer
- What is being tested?
- Focal High Intensity Focused Ultrasound (HIFU) treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2014to 23 Feb 2017
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 80 years (inclusive) with a life expectancy of more than 5 years.
- PSA ≤ 10 ng / mL.
- Initial diagnosis of localized prostate cancer (stage T1 or T2).
- Diagnosis confirmed by a multiparametric MRI and subsequent systematic and targeted prostate biopsies (at least 12 sextant biopsies and two biopsies per MRI target).
- Identification of a primary cancer site (index tumor) possibly associated with a second independent tumor (accessory tumor), provided that these tumors are separated by a sextant or the median line.
- Maximum two cancer foci, each one fulfilling the following conditions
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- Gleason score of 6 AND biopsy invasion length ≥5 mm,
- OR Gleason score of 6 AND corresponding focal lesion on MRI with a PIRADS (Prostate Imaging Reporting and Data System) score ≥4/5 and a diameter ≥5 mm,
- OR Gleason score of 7 (3+4) whatever the biopsy invasion length or the MRI results may be.
- Patient with normal anal and rectal anatomy.
- Patient with a condition corresponding to an ASA (American Society of Anesthesiologists) classification 1 or 2.
- Patient for which treatment by focal HIFU (without performing an associated TURP) has been validated in Multidisciplinary meeting.
- Accepting patient monitoring constraints defined in the context of the study.
- Patient affiliated to health insurance or beneficiary a similar plan.
Who cannot join
- Patient with ASA (American Society of Anesthesiologists) score 3.
- Patient clinical stage T3.
- Metastatic or distant (CT and/or MRI) lymph node.
- Patient with more than two cancer foci.
- Patients already treated for his prostate cancer (hormone therapy, radiotherapy, surgery).
- Patient having a distance between the rectal mucosa and the prostatic capsule over 8 mm.
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- History of inflammatory bowel disease, rectal or urinary tract fistula.
- History of pelvic radiotherapy.
- History of bladder cancer.
- History of sclerosis of the bladder neck or urethral stricture.
- Patient with an implant located at least 1 cm of the treatment zone (stent, catheter).
- Hemorrhagic risk patient.
- Urogenital infection in progress.
- Latex allergy.
- Allergy to sulfur hexafluoride or any of the other components of SonoVue®.
- Patients with recent acute coronary syndrome or unstable ischemic heart disease: myocardial infarction phase formation or evolution, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent intervention on the coronary arteries or other factors suggesting clinical instability (eg recent ECG changes, changes in clinical or laboratory parameters), acute heart failure, heart failure stage III or IV, or severe rhythm disorders (contra-indications to the use of SonoVue®).
- Patient with a right to left shunt, severe pulmonary hypertension (pulmonary artery pressure> 90 mm Hg), uncontrolled systemic hypertension.
- Patient with respiratory distress syndrome.
- Patient with severe chronic obstructive pulmonary disease.
- Patient with acute endocarditis, prosthetic valve holder, acute systemic inflammation and / or sepsis, hyper coagulation status and / or recent thromboembolism.
- Patient on life support or suffering from unstable neurological diseases.
- Contra-indication for MRI (pacemakers, metal prosthesis, etc ...).
- Patient participating or having participated in another clinical study within the last 30 days.
- Patient deprived of liberty following a judicial or administrative decision.
- Patient under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance.
This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.
- Conditions
- Localized Prostate Cancer
- Being tested
- Focal High Intensity Focused Ultrasound (HIFU) treatment
- Keywords
- HIFU, Prostate Cancer, Focal, Quality of life, Index study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal High Intensity Focused Ultrasound (HIFU) treatmentDevice
Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.
| Study group | Role | What they receive |
|---|---|---|
| Localized prostate cancer, Focal treatment. | Other | Not described Receives: Device: Focal High Intensity Focused Ultrasound (HIFU) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Biopsy Rate in the treated area
Measured: Between 6 to 12 months after treatment
Secondary outcomes (7)
Evaluation of positive biopsy rate in the untreated areas
Measured: Between 6 to 12 months after treatment
Rate of side effects
Measured: At 12 and 24 months after treatment
Prostate Specific Antigen (PSA) level evolution after treatment
Measured: 24 months
Prostate Symptoms
International Prostate Symptoms Score (IPSS) questionnaire
Measured: 1 and 2 years(s)
Continence
International Continence Society (ICS) questionnaire
Measured: 1 and 2 years(s)
Erectile Function
International Index Erectile Function (IIEF-5) questionnaire
Measured: 1 and 2 years(s)
Quality of life
European Organization for Research and Treatment Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire
Measured: 1 and 2 years(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start13 Jan 2014
- Primary completionJan 2016
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662673
- Sponsor's protocol ID
- 2013-817
- Acronym
- IDITOP-3
- Status last verified
- Feb 2018
- First submitted
- 18 Jan 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device
- ClinicalTrials.gov ID
- NCT02662673
- Acronym / sponsor ID
- IDITOP-3 / 2013-817
- Conditions
- Localized Prostate Cancer
- Keywords
- HIFU, Prostate Cancer, Focal, Quality of life, Index study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Jan 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 25 Jan 2016 (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.
Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance.
This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Localized prostate cancer, Focal treatment. | Other | Device: Focal High Intensity Focused Ultrasound (HIFU) treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age between 50 and 80 years (inclusive) with a life expectancy of more than 5 years.
- PSA ≤ 10 ng / mL.
- Initial diagnosis of localized prostate cancer (stage T1 or T2).
- Diagnosis confirmed by a multiparametric MRI and subsequent systematic and targeted prostate biopsies (at least 12 sextant biopsies and two biopsies per MRI target).
- Identification of a primary cancer site (index tumor) possibly associated with a second independent tumor (accessory tumor), provided that these tumors are separated by a sextant or the median line.
Key exclusion criteria (25 listed)
- Patient with ASA (American Society of Anesthesiologists) score 3.
- Patient clinical stage T3.
- Metastatic or distant (CT and/or MRI) lymph node.
- Patient with more than two cancer foci.
- Patients already treated for his prostate cancer (hormone therapy, radiotherapy, surgery).
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 |
|---|---|---|
| Focal High Intensity Focused Ultrasound (HIFU) treatmentFocal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device. | Device | Localized prostate cancer, Focal treatment. |
Primary outcome
Negative Biopsy Rate in the treated area
Time frame: Between 6 to 12 months after treatment
7 secondary outcomes
Evaluation of positive biopsy rate in the untreated areas
Time frame: Between 6 to 12 months after treatment
Rate of side effects
Time frame: At 12 and 24 months after treatment
Prostate Specific Antigen (PSA) level evolution after treatment
Time frame: 24 months
Prostate Symptoms
Time frame: 1 and 2 years(s)
Continence
Time frame: 1 and 2 years(s)
Erectile Function
Time frame: 1 and 2 years(s)
Quality of life
Time frame: 1 and 2 years(s)
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 28 Feb 2018.
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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 study testing Focal High Intensity Focused Ultrasound (HIFU) treatment in people with Localized Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
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 14 inclusion and 25 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 28 Feb 2018. 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 France. 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 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?
Negative Biopsy Rate in the treated area (time frame: Between 6 to 12 months after 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 28 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.