HYPo-fractionated Radiotherapy of Lymph Node Metastases guided by NanO-MRI in Prostate Cancer Patients: A Pilot Study (HYPNO-study). - HYPNO-trial

Radboud University Medical Center0 个研究点目标入组 20 人开始时间: 2021年8月10日最近更新: 2021年10月8日

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•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- Biochemical recurrent prostate adenocarcinoma after radical prostatectomy.
•- PSA level = 0.2 ng/ml
•- No macroscopic disease on PSMA-PET/CT
•- No local recurrence on MRI.
•- = 4 foci harbouring regional lymph node metastases (up to 6 nodes in total) on nano-MRI (below aortic bifurcation).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•- If any of the inclusion criteria does not apply.
•- Concurrent or previous androgen deprivation therapy.
•- Previous pelvic radiotherapy.
•- Active inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
•- Contraindication for MR-imaging according to local Radiology protocol or unable to undergo MR-linac treatment (e.g. due to claustrophobia or body circumference).
•- Ferro-magnetic objects in the pelvis or hip causing disturbing susceptibility artifacts (at the discretions of the radiologist).
•- Inability to give informed consent.
•- Contraindications to Ferrotran as stated in the SPC (including no consent to practice contraception until end of study in case of female partners of childbearing potential).

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