Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CS Diagnostics GmbH
With
Aix Scientifics
The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Patient is suffering from pathologically confirmed T1-T2, N0, M0 prostate adenocarcinoma.
Patient is intended to receive radiation therapy (3D-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy.
Patient is intended to receive SpaceOAR™ Gel therapy.
The patient is official patient of the clinical investigator in the study centre.
Patient agrees to fully participate in the clinical trial and give informed consent in writing.
You may not be if
Anatomic abnormality, physical or pathological condition precluding the implantation.
Failure in the wall of the perineum room (with the risk that the hydrogel escapes).
History of prostate surgery or local prostate cancer therapy.
Rectal injury before implantation of SpaceOAR™ Gel or history of or active inflammatory rectal disease such as Crohn's disease or ulcerative colitis.
History of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula.
Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, auto¬immune disease or immunosuppressive therapy).
Platelet count, partial thromboplastin time, or white blood cell count out of normal laboratory range.
Contraindication for safe MRI and CT scans.
Patient is not able to fully participate in this study including the follow-up (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes).
Patient is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation.
Patient has restricted legal capacity.
Patient did participate in another clinical investigation during the last 3 months.
