Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

Inclusion Criteria:

* 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.

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.