Clinical trial NCT01999660: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer Patients Treated by Radiotherapy
Keywords: Prostatic Neoplasms
Radiotherapy
rectal toxicity
Lead sponsor: CS Diagnostics GmbH
Sponsor class: INDUSTRY
Collaborators: name: Aix Scientifics
First posted: 2013-12-03
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™

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

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.

Primary outcomes:
measure: the rectal complication rate (late toxicity)
timeFrame: 6 months and yearly for 5 years thereafter
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months and for 5 years yearly thereafter
Other outcomes:
measure: feasibility of the implantation procedure
timeFrame: 1 day
Locations:
city: Gelsenkirchen
country: Germany
facility: Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen
state: NRW
Study officials:
affiliation: Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany
name: Razvan Galalae, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: