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

NCT01999660•CS Diagnostics GmbH

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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

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.
+3 more criteria

Locations (1)

Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen

Gelsenkirchen, North Rhine-Westphalia, Germany

Key Dates

Start Date

November 1, 2013

Primary Completion Date

August 1, 2019

Completion Date

August 1, 2019

Last Updated

July 27, 2021

Enrollment

119

ACTUAL participants

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Interventions

SpaceOAR™ implantation

DEVICE

Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

NCT07325721

Prostate CancerProstate Cancer Patients Treated by Radiotherapy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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