Innovative Planning and Guidance System for Prostate Focal Brachytherapy (FOCUS)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ACQUISITION OF IMAGES
Sponsored by

About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CHRU de Brest
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ACQUISITION OF IMAGES
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adjustement of doses
The dosimetric planning will be adjusted using the predictive model of the evolution of the prostate volume.
Full Information
NCT ID
NCT03160365
First Posted
May 17, 2017
Last Updated
December 16, 2021
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03160365
Brief Title
Innovative Planning and Guidance System for Prostate Focal Brachytherapy
Acronym
FOCUS
Official Title
Innovative Planning and Guidance System for Prostate Focal Brachytherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2018 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The patient will have some exams more than in the current way
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACQUISITION OF IMAGES
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ACQUISITION OF IMAGES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acquisition images
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Adjustement of doses
Description
The dosimetric planning will be adjusted using the predictive model of the evolution of the prostate volume.
Time Frame
1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Innovative Planning and Guidance System for Prostate Focal Brachytherapy
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