Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

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

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

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer Patients Treated by Radiotherapy
• Intervention / Treatment: Device: SpaceOAR™ implantation

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rectal complication rate (late toxicity)	the rectal complication rate following the common toxicity criteria (CTC) v. 2.0	6 months and yearly for 5 years thereafter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	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).	6 months and for 5 years yearly thereafter

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of the implantation procedure	feasibility of the implantation procedure will be documented by subjective description given by the investigators. this includes safety aspects.	1 day

Collaborators and Investigators

• Sponsor: CS Diagnostics GmbH
• Collaborators: Aix Scientifics
• Investigators: Principal Investigator: Razvan Galalae, PD Dr. med., Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Radiotherapy; Prostatic Neoplasms; rectal toxicity
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Space-CS-01