Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

Exclusion Criteria

• •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.
• •Patient has revoked the consent.