| Eligibility |
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.
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