Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™

NCT01999660 | Terminated

• 1 other identifier: Space-CS-01
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Keywords

Prostatic Neoplasms; Radiotherapy; rectal toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life

  6 months and for 5 years yearly thereafter

Other Outcomes (1)

• feasibility of the implantation procedure

  1 day

Study Arms (1)

SpaceOAR™

prostate cancer patient prophetically treated by SpaceOAR™

Device: SpaceOAR™ implantation

Interventions

SpaceOAR™ implantation DEVICE

SpaceOAR™

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CS Diagnostics GmbH: lead
• Aix Scientifics: collaborator

Study Sites (1)

Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Razvan Galalae, PD Dr. med.

  Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

DE (1)