Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™
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|ClinicalTrials.gov Identifier: NCT01999660|
Recruitment Status : Terminated (PI did leave hospital (retired))
First Posted : December 3, 2013
Last Update Posted : July 27, 2021
|Condition or disease||Intervention/treatment|
|Prostate Cancer Patients Treated by Radiotherapy||Device: SpaceOAR™ implantation|
|Study Type :||Observational|
|Actual Enrollment :||119 participants|
|Official Title:||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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 2019|
prostate cancer patient prophetically treated by SpaceOAR™
Device: SpaceOAR™ implantation
- the rectal complication rate (late toxicity) [ Time Frame: 6 months and yearly for 5 years thereafter ]the rectal complication rate following the common toxicity criteria (CTC) v. 2.0
- Quality of Life [ Time Frame: 6 months and for 5 years yearly thereafter ]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).
- feasibility of the implantation procedure [ Time Frame: 1 day ]feasibility of the implantation procedure will be documented by subjective description given by the investigators. this includes safety aspects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999660
|Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen|
|Gelsenkirchen, NRW, Germany, 45879|
|Principal Investigator:||Razvan Galalae, PD Dr. med.||Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany|