Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006409

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006409
  •   2014/12/02
  •   2013/11/26
  •   no
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Secondary IDs

  •   NCT01999660  (ClinicalTrials.gov)
  •   Space-CS-01  (CS Diagnostics GmbH)
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Health Condition or Problem studied

  •   Prostate Cancer Patients Treated by Radiotherapy
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Device: SpaceOAR™ implantation
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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

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Secondary Outcome

- 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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/11/30
  •   250
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • CS Diagnostics GmbH
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    • Aix Scientifics
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    • Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany
    • Razvan Galalae, PD Dr. med. 
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    • Eike G. Fischer, Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.