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:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT00775866
Eligibility Criteria:
Inclusion Criteria:
* Biochemical failure \> 18 months after definitive external beam radiotherapy (ASTRO definition - revised version 2006: rise by 2 ng/mL or more above the nadir PSA)
* PSA \<20 prior to initial course of external beam radiotherapy
* PSADT \>3 months at failure
* Age ≥ 18 years
* ECOG performance status 0 or 1 with \>10 year life expectancy
* Fit for local anaesthesia
* Informed consent:
Exclusion Criteria:
* Contraindications to MRI
* Severe claustrophobia
* Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding brachytherapy
* Previous brachytherapy
* Active hormonal therapy
* Radiologic evidence of LN or distant metastases
* Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy.
* Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
* Contraindications to conscious sedation
* Contraindication to IV Gadolinium administration
* latex allergy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00775866
Study Brief:
Protocol Section:
NCT00775866