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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

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

Condition or disease Intervention/treatment
Prostate Cancer Patients Treated by Radiotherapy Device: SpaceOAR™ implantation

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

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Study Type : Observational
Actual Enrollment : 119 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
prostate cancer patient prophetically treated by SpaceOAR™
Device: SpaceOAR™ implantation

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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).

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01999660

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Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen
Gelsenkirchen, NRW, Germany, 45879
Sponsors and Collaborators
CS Diagnostics GmbH
Aix Scientifics
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Principal Investigator: Razvan Galalae, PD Dr. med. Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany
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Responsible Party: CS Diagnostics GmbH Identifier: NCT01999660    
Other Study ID Numbers: Space-CS-01
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Keywords provided by CS Diagnostics GmbH:
Prostatic Neoplasms
rectal toxicity
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases