Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant. (CURIEFOCALE)
Primary Purpose
Localized Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Focal brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Localized Prostate Cancer focused on measuring Prostate cancer, permanent implant brachytherapy, image fusion, focal therapy, active surveillance
Eligibility Criteria
Inclusion Criteria:
- Men of more than 18 years old
Patient with localized prostate cancer with a good prognosis (AMICO classification), ie satisfying the following conditions according to the urologist medical record transmitted:
- Lesion classified T1c or T2a based on digital rectal exam
- histologically proven diagnosis of prostatic adenocarcinoma with a Gleason score ≤ 6
- Serum Prostatic Specific Antigen (PSA) <10ng/ml
- Patient for whom the Multidisciplinary Consultative Meeting (RCP) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
- Patient with good micturating function at inclusion, defined by IPSS score <10 (IPSS Questionnaire)
- Patient for whom the result of centralized PSA assay confirms a serum level < 10ng/ml
- Patient for whom the unique and intracapsular character of the target area (area to be treated) was confirmed on pre implantation multimodal MRI imaging (ESUR Score ≥ 9) and whose major axis has a size ≤ 20 mm
- Patient with a Gleason score on the target ≤ 6 (3 +3) confirmed on biopsies performed using KOELIS ® system and with no other derogatory criteria such as the invasion of the entire core or the presence of a grade 4 or perineural emboli
- Patients without history of transurethral resection that could have significantly modified the anatomy of the gland nor obstructive adenoma
- Patient who accepts, at the end of the study, the principle of active surveillance for the rest of the gland and the treated area according to the current standard protocol
- WHO ≤ 2
- Patient with life expectancy > 10 years
- Informed consent obtained and signed before any specific procedure in the study
- Patient affiliated to social security regimen
Exclusion Criteria:
- Image in favour of the crossing of the capsule, based on pre-implantation multimodal MRI (stage T2 MRI only)
- Image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal MRI (stage T2 MRI only)
- Multifocal lesions (ESUR ≥ 9/15) to the pre-implantation multimodal MRI and for which biopsies have shown the cancerous nature
- Lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal MRI
- Patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
- Patient with current indication against prostate brachytherapy, including a significant limitation of the mobility of the hips, a prostate volume greater than 60 cm3 (measured by planimetry MRI) or a significant dysuria (IPSS ≥ 10)
- Patient unable to follow procedures, visits, examinations described in the the study
- Patient with absolute indication against imaging tests (significant claustrophobia, wearing a heart valve, pacemaker, ..)
- Man of childbearing age who do not want follow the instructions about sexual activities and condom use during the days following the treatment of brachytherapy and / or unwilling to hold (him or her partner) effective contraception for the duration of the study
- Any concomitant or previous malignant disease in the past five years with the exception of superficial basal cell carcinoma or non-metastatic of the skin
- Any prior systemic chemotherapy within 5 years prior to inclusion for malignant disease in the medical history
- Any coexisting medical condition that in the opinion of the investigator could be a risk in this study
- Patient protected by law
Sites / Locations
- Institut Claudius REGAUD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Focal brachytherapy
Arm Description
Focal brachytherapy with permanent I125 localized implant.
Outcomes
Primary Outcome Measures
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30
Secondary Outcome Measures
Progression-free-survival according to Phoenix criterion
Progression-free-survival is defined as the time from patient inclusion to the date of biological progression according to Phoenix criterion
Quality of life study using 3 Patient questionnaires
Quality of life will be evaluated using 3 Patient questionnaires : the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire, the International Index of Erectile Function Questionnaire and the International Prostate Symptom Score Questionnaire
Absence of tumor residuals in the target treated zone
The absence of tumor residuals in the target treated zone will be evaluated on on biopsies performed 1 year after implantation
Toxicity evaluation
Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01902680
Brief Title
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
Acronym
CURIEFOCALE
Official Title
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 23, 2013 (Actual)
Primary Completion Date
July 7, 2016 (Actual)
Study Completion Date
June 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up).
The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Prostate Cancer
Keywords
Prostate cancer, permanent implant brachytherapy, image fusion, focal therapy, active surveillance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focal brachytherapy
Arm Type
Experimental
Arm Description
Focal brachytherapy with permanent I125 localized implant.
Intervention Type
Radiation
Intervention Name(s)
Focal brachytherapy
Intervention Description
Focal brachytherapy with permanent I125 localized implant.
Primary Outcome Measure Information:
Title
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
Description
Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression-free-survival according to Phoenix criterion
Description
Progression-free-survival is defined as the time from patient inclusion to the date of biological progression according to Phoenix criterion
Time Frame
3 years
Title
Quality of life study using 3 Patient questionnaires
Description
Quality of life will be evaluated using 3 Patient questionnaires : the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire, the International Index of Erectile Function Questionnaire and the International Prostate Symptom Score Questionnaire
Time Frame
3 years
Title
Absence of tumor residuals in the target treated zone
Description
The absence of tumor residuals in the target treated zone will be evaluated on on biopsies performed 1 year after implantation
Time Frame
3 years
Title
Toxicity evaluation
Description
Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men of more than 18 years old
Patient with localized prostate cancer with a good prognosis (AMICO classification), ie satisfying the following conditions according to the urologist medical record transmitted:
Lesion classified T1c or T2a based on digital rectal exam
histologically proven diagnosis of prostatic adenocarcinoma with a Gleason score ≤ 6
Serum Prostatic Specific Antigen (PSA) <10ng/ml
Patient for whom the Multidisciplinary Consultative Meeting (RCP) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
Patient with good micturating function at inclusion, defined by IPSS score <10 (IPSS Questionnaire)
Patient for whom the result of centralized PSA assay confirms a serum level < 10ng/ml
Patient for whom the unique and intracapsular character of the target area (area to be treated) was confirmed on pre implantation multimodal MRI imaging (ESUR Score ≥ 9) and whose major axis has a size ≤ 20 mm
Patient with a Gleason score on the target ≤ 6 (3 +3) confirmed on biopsies performed using KOELIS ® system and with no other derogatory criteria such as the invasion of the entire core or the presence of a grade 4 or perineural emboli
Patients without history of transurethral resection that could have significantly modified the anatomy of the gland nor obstructive adenoma
Patient who accepts, at the end of the study, the principle of active surveillance for the rest of the gland and the treated area according to the current standard protocol
WHO ≤ 2
Patient with life expectancy > 10 years
Informed consent obtained and signed before any specific procedure in the study
Patient affiliated to social security regimen
Exclusion Criteria:
Image in favour of the crossing of the capsule, based on pre-implantation multimodal MRI (stage T2 MRI only)
Image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal MRI (stage T2 MRI only)
Multifocal lesions (ESUR ≥ 9/15) to the pre-implantation multimodal MRI and for which biopsies have shown the cancerous nature
Lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal MRI
Patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
Patient with current indication against prostate brachytherapy, including a significant limitation of the mobility of the hips, a prostate volume greater than 60 cm3 (measured by planimetry MRI) or a significant dysuria (IPSS ≥ 10)
Patient unable to follow procedures, visits, examinations described in the the study
Patient with absolute indication against imaging tests (significant claustrophobia, wearing a heart valve, pacemaker, ..)
Man of childbearing age who do not want follow the instructions about sexual activities and condom use during the days following the treatment of brachytherapy and / or unwilling to hold (him or her partner) effective contraception for the duration of the study
Any concomitant or previous malignant disease in the past five years with the exception of superficial basal cell carcinoma or non-metastatic of the skin
Any prior systemic chemotherapy within 5 years prior to inclusion for malignant disease in the medical history
Any coexisting medical condition that in the opinion of the investigator could be a risk in this study
Patient protected by law
Facility Information:
Facility Name
Institut Claudius REGAUD
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
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