Prostate Cancer Patients Treated by Radiotherapy
Conditions
Keywords
Prostatic Neoplasms, Radiotherapy, rectal toxicity
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
Interventions
DEVICESpaceOAR™ implantation
Sponsors
Aix Scientifics
CS Diagnostics GmbH
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rectal complication rate (late toxicity) | 6 months and yearly for 5 years thereafter | the rectal complication rate following the common toxicity criteria (CTC) v. 2.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| feasibility of the implantation procedure | 1 day | feasibility of the implantation procedure will be documented by subjective description given by the investigators. this includes safety aspects. |
Countries
Germany
Outcome results
None listed