Single fraction high-dose-rate brachytherapy monotherapy in prostate cancer * Phase I-II trial - Single fraction HDR-BT

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Men aged 18-80 years
•Histological confirmation of prostate adenocarcinoma
•Gleason score * 7
•Clinical stage T1c-T2a, N0-X, M0
•PSA * 15 ng/ml
•WHO performance status 0-2
•Prostate volume * 50 ml
•IPSS score * 12
•Maximum urinary flow rate * 15 ml/s at uroflowmetry and residual volume of < 100 ml
•Ability and willingness to comply with follow-up and completion of questionnaires
•Written informed consent.

•Previous malignancy within the last 5 years, except basal cell carcinoma or squamous cell carcinoma of the skin
•In case of Gleason score 7: more than 3 positive biopsies
•Prior pelvic radiotherapy
•Prior androgen deprivation therapy (including androgen agonists and antagonists)
•Any prior active treatment for prostate cancer (Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria)
•Life expectancy <5 years
•Prior TURP (transurethral resection of the prostate)
•Co-morbidity preventing general or spinal anesthesia
•Hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
•Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease or significant urinary symptoms
•Anticoagulation with coumarins or bleeding tendency making brachytherapy unsafe in the opinion of the clinician
•Medical condition or implant that prohibits MRI imaging
•Participation in another concurrent treatment protocol.

发起方