MR-guided focal cryosurgery of the prostate: a pilot study* - MR-guided focal cryosurgery

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•We plan to enroll thirty patients in total, divided over two groups; A and B. Ten patients with newly diagnosed and pathological proven PCa, which have a tumor confined to one prostate lobe and which is not located near the neurovascular bundle and no prior hormonal or radiation treatment will be included in group A. In group B twenty patients with biopsy-proven local recurrence of the prostate without distant metastases after radiotherapy will be included.;Additional inclusion criteria counting for both groups:
•18 years of age or more
•Pathologically proven PCa
•Signed screening form (to search for metal device/foreign bodies/claustrophobia)
•Signed IRB-approved informed consent form

•Impossibility to obtain a valid informed consent
•Patients unable to undergo MR imaging, including those with contra-indications
•Contra-indications to MR guided cryosurgery (colitis ulcerosa, rectal pathology or dominoperineal resection)
•Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
•A prostate volume > 50 mL
•No data available from whole-mount step-section pathologic analysis to use as reference standard (group A)

发起方

niversitair Medisch Centrum Sint Radboud