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

Intervention:

  • 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 2013

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

Contact:

  • Eike G. Fischer, Dr.
  • +49 241 4500 358

Location:

  • Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen
  • Gelsenkirchen NRW 45879 Germany

View trial on ClinicalTrials.gov


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