Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

Study Overview
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Brief Summary
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A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients

Detailed Description
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The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum

Official Title
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Prospective National Post-marketing Surveillance for the Investigation of the Efficacy and Safety of SpaceOAR™ to Maintain Space Between the Rectum and Prostate During Radiation Therapy

Conditions
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Prostate Cancer Patients Treated by Radiotherapy

Intervention / Treatment
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* Device: SpaceOAR™ implantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SpaceOAR™<br>prostate cancer patient prophetically treated by SpaceOAR™ | Device: SpaceOAR™ implantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rectal complication rate (late toxicity) | the rectal complication rate following the common toxicity criteria (CTC) v. 2.0 | 6 months and yearly for 5 years thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | The validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire in combination with the validated Short Form Health Survey (SF-12) will be used to document the influence on the quality of life (QoL). | 6 months and for 5 years yearly thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, Radiotherapy, rectal toxicity