Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01999660
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01999660
Study Brief:
Protocol Section:
NCT01999660