Prostate CancerFOCUSNCT03160365
Innovative Planning and Guidance System for Prostate Focal Brachytherapy
A study testing ACQUISITION OF IMAGES in people with Prostate Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
A key feature of low-dose brachytherapy is that irradiation affects only a local area around the inserted radiation sources. The exposure of healthy tissues around these sources is then reduced. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ACQUISITION OF IMAGES
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2018to 25 May 2021
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for prostate brachytherapy
- Male patients, aged at least 18 years with no age limit.
- Prostate adenocarcinoma with proved histology (prostate biopsy)
- Localized disease: Negative extension (TAP + TAP + bone scintigraphy)
- Absence of contraindications to surgery or general anesthesia Prostatic volume less than or equal to 60 cc
- Prognostic group of "low risk" according to the classification of D'Amico (Gleason less than or equal to 6 AND PSA <10ng / ml AND less than or equal to T2a to the rectal touch)
Show all 13Show fewer
- Prognostic group "favorable intermediate" according to the classification of D'Amico (with no more than one criterion among the following: Gleason 7 (3 + 4), PSA <15ng / ml, less than half of the positive biopsies). Note: Gleason 7 (4 + 3) are excluded.
- Absence of prophylactic capsular collapse on prostatic MRI
- Absence of irritative urinary signs too important
- No history of pelvic irradiation
- Absence of colorectal inflammatory disease in evolutionary thrust
- Informed Consent
- Affiliated to a social security scheme or beneficiary
Who cannot join
- A protected major person within the meaning of the Public Health Code
- Refus or inability to give informed consent
- NO-indication to CT SCAN and MRI
Trial locations and contacts
1 site in 1 country.
About this study
A key feature of low-dose brachytherapy is that irradiation affects only a local area around the inserted radiation sources. The exposure of healthy tissues around these sources is then reduced. However, the number of adverse events remains high (about 79% of patients with sexual problems and 30% of patients with urinary incontinence) and brachytherapy is no better than other treatment options for Preservation of the urethral apparatus (about 40% of patients).
The current technique for the implantation of radioactive sources, which has not been revised since the early 1980s, consists in imaging the prostate at the beginning of the intraoperative procedure with transrectal ultrasound in order to evaluate the size and shape of the prostate . This information is then used to identify the best distribution of the dose of radiation to be administered to each patient. This treatment planning step is based on a procedure where the operator manually places 50 to 100 grains of iodine in the prostate. These grains are inserted transperinally under transrectal 2D ultrasound control, using needles through a transperineal grid with several needle guides evenly spaced 5 mm apart. This is an arduous task because this manual grain placement procedure must take into account the dose to be administered to the prostate without exceeding the dose limit for the surrounding organs at risk (rectum, urethra). In addition, the overestimation of the dose formality called TG-43 and the inaccurate grain placement can contribute to the creation of cold spots where no dose is administered. It may be responsible for recurrences of prostate cancer after brachytherapy treatment. Although brachytherapy dosimetry has been extensively researched, the TG-43 dose formalism has been the benchmark for the last 20 years. Moreover, from an economic point of view, the high side-effects rates of the treatment of prostate cancer result in particularly expensive post-treatment costs. The search for improved solutions for the treatment of prostate cancer remains a major societal challenge.
Read more
In recent years, a very attractive therapeutic alternative between active surveillance and overall treatment is gaining popularity among experts: focal therapy.
It is a localized treatment, limited to cancerous areas, in order to preserve healthy functional tissues inside and outside the organ and thus the quality of life of the patient.
Focal therapy is also often the preferred solution for recovery therapy (second intervention).
Finally, focal therapy has great potential to reduce the cost and duration of the intervention, as well as the cost of follow-up.
In recent years, several energies have been proposed as being adapted to focal therapy, such as high intensity focal ultrasound, laser ablation and cryotherapy. Brachytherapy, which already gives above average results in the treatment of whole glands, has been identified as a very good candidate for this new therapeutic paradigm.
In brachytherapy, radioactive grains are implanted in the prostate using transperineal catheters. The rapid reduction of the dose according to the distance of the radioactive seeds gives the physician a great flexibility to control the radiation accurately. It allows intermediate approaches between global and focal treatments, providing great scalability, and it is a good candidate for recovery therapy.
Recent studies have shown that focal brachytherapy allows more than half of the needles and seeds to act more strongly on the target while irradiating Significantly less The urethra and rectum. Clinical studies on this subject are still limited and further research is needed to confirm the performance of this approach.
- Conditions
- Prostate Cancer
- Being tested
- ACQUISITION OF IMAGES
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACQUISITION OF IMAGESProcedure or surgery
In addition to the conventional clinical protocol, 4 MRIs qere performed at Day 0, day 1,day 15 and day 30 and a preoperative CT scan without injection of a contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| ACQUISITION OF IMAGES | Other | 4 MRIs were performed at Day 0, day 1, day 15 and day 30 and a preoperative CT scan without injection of a contrast agent. Receives: Procedure: ACQUISITION OF IMAGES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition images
The volume of the prostate was evaluated from acquisition of CT and MRI after brachytherapy which causes an increase of it following the insertion of the needles to create a predictive model.
Measured: 1 month
Secondary outcomes (1)
Adjustement of doses
The dosimetric planning will be adjusted using the predictive model of the evolution of the prostate volume.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start6 Apr 2018
- Primary completion25 May 2021
- Study completion25 May 2021
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.
- More trials run by University Hospital, BrestThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patient will have some exams more than in the current way
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160365
- Sponsor's protocol ID
- 29BRC17.0094 FOCUS
- Acronym
- FOCUS
- Status last verified
- Dec 2021
- First submitted
- 17 May 2017
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Planning and Guidance System for Prostate Focal Brachytherapy
- ClinicalTrials.gov ID
- NCT03160365
- Acronym / sponsor ID
- FOCUS / 29BRC17.0094 FOCUS
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 19 May 2017 (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.
A key feature of low-dose brachytherapy is that irradiation affects only a local area around the inserted radiation sources. The exposure of healthy tissues around these sources is then reduced. However, the number of adverse events remains high (about 79% of patients with sexual problems and 30% of patients with urinary incontinence) and brachytherapy is no better than other treatment options for Preservation of the urethral apparatus (about 40% of patients).
The current technique for the implantation of radioactive sources, which has not been revised since the early 1980s, consists in imaging the prostate at the beginning of the intraoperative procedure with transrectal ultrasound in order to evaluate the size and shape of the prostate . This information is then used to identify the best distribution of the dose of radiation to be administered to each patient. This treatment planning step is based on a procedure where the operator manually places 50 to 100 grains of iodine in the prostate. These grains are inserted transperinally under transrectal 2D ultrasound control, using needles through a transperineal grid with several needle guides evenly spaced 5 mm apart. This is an arduous task because this manual grain placement procedure must take into account the dose to be administered to the prostate without exceeding the dose limit for the surrounding organs at risk (rectum, urethra). In addition, the overestimation of the dose formality called TG-43 and the inaccurate grain placement can contribute to the creation of cold spots where no dose is administered. It may be responsible for recurrences of prostate cancer after brachytherapy treatment. Although brachytherapy dosimetry has been extensively researched, the TG-43 dose formalism has been the benchmark for the last 20 years. Moreover, from an economic point of view, the high side-effects rates of the treatment of prostate cancer result in particularly expensive post-treatment costs. The search for improved solutions for the treatment of prostate cancer remains a major societal challenge.
In recent years, a very attractive therapeutic alternative between active surveillance and overall treatment is gaining popularity among experts: focal therapy.
It is a localized treatment, limited to cancerous areas, in order to preserve healthy functional tissues inside and outside the organ and thus the quality of life of the patient.
Focal therapy is also often the preferred solution for recovery therapy (second intervention).
Finally, focal therapy has great potential to reduce the cost and duration of the intervention, as well as the cost of follow-up.
In recent years, several energies have been proposed as being adapted to focal therapy, such as high intensity focal ultrasound, laser ablation and cryotherapy. Brachytherapy, which already gives above average results in the treatment of whole glands, has been identified as a very good candidate for this new therapeutic paradigm.
In brachytherapy, radioactive grains are implanted in the prostate using transperineal catheters. The rapid reduction of the dose according to the distance of the radioactive seeds gives the physician a great flexibility to control the radiation accurately. It allows intermediate approaches between global and focal treatments, providing great scalability, and it is a good candidate for recovery therapy.
Recent studies have shown that focal brachytherapy allows more than half of the needles and seeds to act more strongly on the target while irradiating Significantly less The urethra and rectum. Clinical studies on this subject are still limited and further research is needed to confirm the performance of this approach.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patient will have some exams more than in the current way
| Arm | Type | Receives |
|---|---|---|
| ACQUISITION OF IMAGES | Other | Procedure: ACQUISITION OF IMAGES4 MRIs were performed at Day 0, day 1, day 15 and day 30 and a preoperative CT scan without injection of a contrast agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients eligible for prostate brachytherapy
- Male patients, aged at least 18 years with no age limit.
- Prostate adenocarcinoma with proved histology (prostate biopsy)
- Localized disease: Negative extension (TAP + TAP + bone scintigraphy)
- Absence of contraindications to surgery or general anesthesia Prostatic volume less than or equal to 60 cc
Key exclusion criteria (3 listed)
- A protected major person within the meaning of the Public Health Code
- Refus or inability to give informed consent
- NO-indication to CT SCAN and MRI
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 |
|---|---|---|
| ACQUISITION OF IMAGESIn addition to the conventional clinical protocol, 4 MRIs qere performed at Day 0, day 1,day 15 and day 30 and a preoperative CT scan without injection of a contrast agent. | Procedure or surgery | ACQUISITION OF IMAGES |
Primary outcome
Acquisition images
Time frame: 1 month
The volume of the prostate was evaluated from acquisition of CT and MRI after brachytherapy which causes an increase of it following the insertion of the needles to create a predictive model.
1 secondary outcome
Adjustement of doses
Time frame: 1 month
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 17 Dec 2021.
- Individual participant dataSharing planned: No
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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 ACQUISITION OF IMAGES in people with Prostate Cancer, run by University Hospital, Brest 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 3 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 17 Dec 2021. 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?
Acquisition images (time frame: 1 month). 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 17 Dec 2021.