Status:
COMPLETED
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Localized Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 veri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01902680
Start Date
August 23 2013
End Date
June 6 2017
Last Update
August 6 2018
Active Locations (1)
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1
Institut Claudius REGAUD
Toulouse, France, 31059