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
Condition: Prostate Cancer Patients Treated by Radiotherapy
- Device: SpaceOAR™ implantation
Purpose: A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients
Study Type: Observational
Clinical Trials Identifier NCT 8-digits: NCT01999660
Sponsor: CS Diagnostics GmbH
Primary Outcome Measures:
- Measure: the rectal complication rate (late toxicity)
- Time Frame: 6 months and yearly for 5 years thereafter
- Safety Issue:
Secondary Outcome Measures:
- Measure: Quality of Life
- Time Frame: 6 months and for 5 years yearly thereafter
- Safety Issue:
Estimated Enrollment: 250
Study Start Date: November 2013Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192
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- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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.
- 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.
- Eike G. Fischer, Dr.
- +49 241 4500 358
- Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen
- Gelsenkirchen NRW 45879 Germany
View trial on ClinicalTrials.gov