Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer - Prostate stereotactic body radiotherapy with a hydrogel spacer

The University of Tokyo Hospital0 sites42 target enrollmentFebruary 20, 2017

Overview

No summary available.

Registry

who.int

Start Date

February 20, 2017

End Date

September 1, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

•Patients with lymph node metastasis and or distant metastasis History of prostate cancer treatment (surgery, high intensity focused ultrasound, chemotherapy) Hormone therapy \>\= 12 months before radiotherapy History of pelvic radiotherapy History of any other malignancy within 2 years (except carcinoma in situ) Severe cardiovascular disease Severe respiratory disease Liver disease (AST, ALT \>20 x ULN) Severe kidney disease requiring hemodialysis Unable to provide written informed consent Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) History of lowerpelvic surgery Metal in pelvic or near pelvic area (e.g. total hip replacement) affecting pelvic CT scan Bleeding tendency that may disrupt hydrogel spacer insertion (Plt \<\= 100000, PT INR \> 1\.5 ULN (with anticoagulant, PT INR \> 2\.5 ULN), APTT \>\= 2 x ULN) Unable to insert ultrasound probe (e.g. anal stenosis) Allergic to local anesthetics Considered not appropriate for the study by investigator