Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

• ClinicalTrials.gov Identifier: NCT01999660
• Recruitment Status: Terminated
• First Posted: December 3, 2013
• Last Update Posted: July 27, 2021
• Sponsor: CS Diagnostics GmbH
• Collaborator: 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

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 21, 2021): 119
• Original Estimated Enrollment (submitted: November 26, 2013): 250
• 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.

Sex/Gender

• 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

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

Investigators

• 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