Cancer of ProstateFOC/DYNNCT03632980
Dynamic Focusing Evaluation for Prostate Cancer Treatment
A study testing "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment in people with Cancer of Prostate, run by EDAP TMS S.A. at 1 site in France.
Trial summary
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer. Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Cancer of Prostate
- What is being tested?
- "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Dec 2019
- 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 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 70 years
- T1 or T2
- PSA < 15 ng/mL
- 12 randomized biopsies
- Gleason score ≤ 3+4
- Normal anal and rectal anatomy
Show all 13Show fewer
- American Society of Anesthesiologists risk (ASA) 1 or 2
- Age > 50 years
- T1 or T2
- Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml)
- 12 randomized biopsies
- Normal anal and rectal anatomy
- ASA 1 or 2
Who cannot join
- T3 patients
- American Society of Anesthesiologists risk (ASA) 3
- Metastatic disease (Bone scan…)
- Previous prostate cancer therapy
- Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
- Prostate volume over 50cc
Show all 17Show fewer
- Previous bladder cancer
- contraindication to MRI
- previous rectal or urinary fistulae
- T3 patients
- ASA 3
- Metastatic disease (Bone scan…)
- Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
- Prostate volume over 50cc
- Previous bladder cancer
- contraindication to MRI
- previous rectal or urinary fistulae
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.
- Conditions
- Cancer of Prostate
- Being tested
- "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
- Keywords
- HIFU, Localized Prostate cancer, MRI, PSA nadir, Biopsy, High Intensity Focused Ultrasound, Prostate Specific Antigen (PSA)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Ablatherm Foc/Dyn" or "Focal One" HIFU treatmentDevice
Also called Ablatherm Foc/Dyn or Ablatherm Foc/Dyn post-radiotherapy, Focal One or Focal One post-radiotherapy, First line treatment or Salvage treatment post-radiotherapy
Non invasive treatment of localized prostate cancer by High Intensity Focused Ultrasound therapy, endorectal application.
or Non invasive treatment of localized prostate cancer recurrency by High Intensity Focused Ultrasound therapy after radiotherapy failure, endorectal application.
| Study group | Role | What they receive |
|---|---|---|
| HIFU prostate treatment | Experimental | The HIFU intervention will concern Primary care patients or Secondary care patients (salvage).
Intervention with "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment devices
HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - First line" to Patients suffering from localized prostate cancer that has not been previously treated or Salvage HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - Post radiotherapy" to subjects harboring prostate cancer recurrency after radiotherapy Receives: Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necrosis measurement (immediate efficacy)
The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.
Measured: Day 7
Secondary outcomes (11)
Histological marker measurement (mid term efficacy)
The mid term efficacy is evaluated by the rate of negative biopsy at 6 months.
Measured: 6 months
Biochemical marker measurement (mid term efficacy)
The mid term efficacy is evaluated by the percentage of patient with a PSA nadir ≤ 0.3ng/mL
Measured: 6 months
Rectal wall preservation (immediate safety and morbidity)
Evaluate the rectal wall preservation by MRI in the first week post treatment.
Measured: Day 7
Adverse events reporting rates (safety and the morbidity) at 6 months
Adverse Events reporting
Measured: 6 months
Adverse events reporting rates (safety and the morbidity) at 24 months
Adverse Events reporting
Measured: 24 months
Quality of life score
Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire.
It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.
Measured: 3 months
Quality of life score
Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire.
It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.
Measured: 6 months
IPSS score
Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire.
The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
Measured: 3 months
IPSS score
Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire.
The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
Measured: 6 months
IIEF-5 score
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire.
The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high).
The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
Measured: 3 months
IIEF-5 score
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire.
The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high).
The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study startJun 2011
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ProstateStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- EDAP TMS S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert GELET, MD, Principal investigator, Edouard Herriot Hospital, Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632980
- Sponsor's protocol ID
- HIFU/F/10.08
- Other IDs
- 2011-A00313-38
- Acronym
- FOC/DYN
- Status last verified
- Aug 2018
- First submitted
- 31 Jan 2012
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters
- ClinicalTrials.gov ID
- NCT03632980
- Acronym / sponsor ID
- FOC/DYN / HIFU/F/10.08
- Conditions
- Cancer of Prostate
- Keywords
- HIFU, Localized Prostate cancer, MRI, PSA nadir, Biopsy, High Intensity Focused Ultrasound, Prostate Specific Antigen (PSA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Aug 2018 (actual)
- 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.
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU prostate treatment | Experimental | Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatmentThe HIFU intervention will concern Primary care patients or Secondary care patients (salvage). Intervention with "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment devices HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - First line" to Patients suffering from localized prostate cancer that has not been previously treated or Salvage HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - Post radiotherapy" to subjects harboring prostate cancer recurrency after radiotherapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Age > 70 years
- T1 or T2
- PSA < 15 ng/mL
- 12 randomized biopsies
- Gleason score ≤ 3+4
Key exclusion criteria (17 listed)
- T3 patients
- American Society of Anesthesiologists risk (ASA) 3
- Metastatic disease (Bone scan…)
- Previous prostate cancer therapy
- Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
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 |
|---|---|---|
| "Ablatherm Foc/Dyn" or "Focal One" HIFU treatmentAlso: Ablatherm Foc/Dyn or Ablatherm Foc/Dyn post-radiotherapy, Focal One or Focal One post-radiotherapy, First line treatment or Salvage treatment post-radiotherapyNon invasive treatment of localized prostate cancer by High Intensity Focused Ultrasound therapy, endorectal application. or Non invasive treatment of localized prostate cancer recurrency by High Intensity Focused Ultrasound therapy after radiotherapy failure, endorectal application. | Device | HIFU prostate treatment |
Primary outcome
Necrosis measurement (immediate efficacy)
Time frame: Day 7
The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.
11 secondary outcomes
Histological marker measurement (mid term efficacy)
Time frame: 6 months
Biochemical marker measurement (mid term efficacy)
Time frame: 6 months
Rectal wall preservation (immediate safety and morbidity)
Time frame: Day 7
Adverse events reporting rates (safety and the morbidity) at 6 months
Time frame: 6 months
Adverse events reporting rates (safety and the morbidity) at 24 months
Time frame: 24 months
Quality of life score
Time frame: 3 months
Quality of life score
Time frame: 6 months
IPSS score
Time frame: 3 months
IPSS score
Time frame: 6 months
IIEF-5 score
Time frame: 3 months
IIEF-5 score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Albert GELET, MD principal investigator
Edouard Herriot Hospital, Lyon, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment in people with Cancer of Prostate, run by EDAP TMS S.A. 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 13 inclusion and 17 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 16 Aug 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?
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?
Necrosis measurement (immediate efficacy) (time frame: Day 7). 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 16 Aug 2018.