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

niversity Medical Center Utrecht (UMCU)0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•Age at least 18 years;
•- Biochemical recurrence according to the RTOG-ASTRO Phoenix definition (PSA >2 ng/ml above nadir) at least 2 years after primary treatment;
•- Stage T3b tumour or lower;
•- Recurrent lesion visible on 68Ga-PSMA-PET-CT and at least 1 sequence of the mp-MRI (T2 weighted (T2W), DCE or DWI);
•- Karnofsky score at least 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.

•- Metastatic disease;
•- Other prostate cancer treatments in the past (HIFU or cryosurgery), except for radiotherapy;
•- Trans-urethral resection of the prostate (TURP) within the past 6 months;
•- Prior radiotherapy for a malignancy in the pelvic area, other than prostate cancer;
•- 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 MRI-scan;
•- Physical inability to spread the legs sufficiently for positioning in the leg supports;
•- Contra-indications for MRI.

发起方

niversity Medical Center Utrecht (UMCU)