CompletedPhase 2

Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.

France18 participantsStarted 2013-08-23

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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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

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)

What they're measuring

Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation

Timeframe: 3 years

Trial details

NCT IDNCT01902680

SponsorInstitut Claudius Regaud

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07-07

View on ClinicalTrials.gov More Localized Prostate Cancer trials