Focal laser ablation (FLA) for the focal treatment of localized prostate cancer - PRO-FLA

Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät0 个研究点目标入组 10 人开始时间: 2021年6月4日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Voluntary written consent after verbal explanation for FLA
•2. Men aged 18–80 years with a life expectancy of at least 10 years
•3. PSA = 15ng / ml
•4. Clinically localized prostate cancer
•5. Correspondence of suspicious mpMRI areas (PI-RADS score 3-5) with areas of positive punches
•6. Gleason score = 3 + 4 = 7a, ISUP category 1 or 2
•7. Maximum size of the lesion visible on MRI 20mm
•8. A maximum of 1 histologically confirmed carcinoma focus
•9. Normal anal and rectal anatomy
•10. Minimum distance of the carcinoma to the rectum 8mm
•11. General anesthesia possible for patient (ASA status 1-2)

•1. Clinical tumor stage not locally limited
•2. Imaging evidence of lymph node metastases, extracapsular spread or distant metastasis
•3. More than one histologically proven carcinoma focus
•4. Punch biopsy carcinoma detection without MR correlate in the same sector
•5. MRI lesions PI-RADS 3-5 that have not been clarified by a targeted biopsy
•6. Existing urethral stenosis
•7. Unresolved coagulation disorders
•8. Untreated urogenital infections
•9. Contraindication to magnetic resonance imaging
•10. Participation in a therapy study on the prostate within the last 30 days
•11. Lack of consent
•12. Ongoing anti-hormonal therapy
•13. Other oncological pretreatments of the prostate such as radiation or HIFU of the same area
•14. Anti-androgen / androgen withdrawal therapy within the last 6 months
•15. Ongoing other oncological therapy

发起方

Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät