Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

NCT ID: NCT01999660

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2019-08-31

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

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

SpaceOAR™

prostate cancer patient prophetically treated by SpaceOAR™

SpaceOAR™ implantation

Intervention Type: DEVICE

Interventions

SpaceOAR™ implantation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aix Scientifics

INDUSTRY

Sponsor Role: collaborator

CS Diagnostics GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Razvan Galalae, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany

Locations

Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen

Gelsenkirchen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Space-CS-01

Identifier Type: -

Identifier Source: org_study_id