RObotic mri-guided high dose rate Brachytherapy Needle implantation in the proState - a proof of concept study - ROBiNSon

niversitair Medisch Centrum Utrecht0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- All eligibility criteria for focal salvage high-dose-rate brachytherapy
•(HDR-BT) as currently followed by the department of Radiotherapy at the UMCU:
•o Age >=18 years;
•o Local recurrence >2 years after primary treatment.
•o Stage <=T3b tumour;
•o Recurrent lesion visible on 68Ga-PSMA-PET-CT and at least 1 sequence of
•the mp-MRI (T2 weighted (T2 weighted (T2W), DCE or DWI);
•o Karnofsky score >=70.
•- Prior prostate cancer treatment with standard external beam radiation therapy
•(EBRT), for which fiducial gold markers were placed in the prostate;
•- Tumour location technically feasible for robotic needle placement as
•determined on diagnostic MRI scan and PET-CT scan;
•- Written informed consent.

•- Any contra-indications for focal salvage HDR-BT as currently followed by the
•department of Radiotherapy at the UMCU:
•o Metastatic disease;
•o Other prostate cancer treatments in the past (HIFU or cryosurgery),
•except for radiotherapy;
•o Trans-urethral resection of the prostate (TURP) within the past 6
•o Prior radiotherapy for a malignancy in the pelvic area, other than
•prostate cancer;
•o Continuously required anticoagulant administration, except for platelet
•aggregation inhibitors (for example Ascal/Persantin).
•- Hypofractionated EBRT as primary prostate cancer treatment;
•- Less than 3 gold markers visible in the prostate on the pre-treatment
•- Physical inability to spread the legs sufficiently for positioning in the leg
•- Contra-indications for MRI.

发起方

niversitair Medisch Centrum Utrecht