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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal brachytherapy | Experimental | Focal brachytherapy with permanent I125 localized implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal brachytherapy | Radiation | Focal brachytherapy with permanent I125 localized implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Quality of life study using 3 Patient questionnaires |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Claudius REGAUD | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29510957 | Result | Graff P, Portalez D, Lusque A, Brun T, Aziza R, Khalifa J, Roumiguie M, Quintyn Ranty ML, Filleron T, Bachaud JM, Malavaud B. IDEAL 2a Phase II Study of Ultrafocal Brachytherapy for Low- and Intermediate-risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Nov 15;102(4):903-911. doi: 10.1016/j.ijrobp.2018.01.066. Epub 2018 Feb 2. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| 3 years |
| 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 | 3 years |
| Toxicity evaluation | Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0 | 3 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |