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Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01999660
Recruitment Status : Terminated (PI did leave hospital (retired))
First Posted : December 3, 2013
Last Update Posted : July 27, 2021
Aix Scientifics
Information provided by (Responsible Party):
CS Diagnostics GmbH

Tracking Information
First Submitted Date November 26, 2013
First Posted Date December 3, 2013
Last Update Posted Date July 27, 2021
Study Start Date November 2013
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2013)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 26, 2013)
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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 26, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™
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
Brief Summary A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients
Detailed Description The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™
Condition Prostate Cancer Patients Treated by Radiotherapy
Intervention Device: SpaceOAR™ implantation
Study Groups/Cohorts SpaceOAR™
prostate cancer patient prophetically treated by SpaceOAR™
Intervention: Device: SpaceOAR™ implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 21, 2021)
Original Estimated Enrollment
 (submitted: November 26, 2013)
Actual Study Completion Date August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
Administrative Information
NCT Number NCT01999660
Other Study ID Numbers Space-CS-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CS Diagnostics GmbH
Study Sponsor CS Diagnostics GmbH
Collaborators Aix Scientifics
Principal Investigator: Razvan Galalae, PD Dr. med. Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany
PRS Account CS Diagnostics GmbH
Verification Date July 2021