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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT00890006
Eligibility Criteria:
Inclusion Criteria:
Low or intermediate risk localized prostate cancer:
* Gleason score ≤ 7
* PSA \<20
* Stage T2a or less (Stage 2 only)
* \<50% of biopsy cores involved with tumor (Stage 2 only)
Exclusion Criteria:
* History of hip replacement
* Inflammatory bowel disease or collagen vascular disease
* Contraindication to fiducial marker placement
* Bleeding diathesis or anticoagulant therapy that cannot safely be ceased temporarily
* Severe adverse event with prior TRUS-guided prostate biopsy
* Patient refuses fiducial marker placement
* Contraindication to MRI
* Patient randomization in PROFIT Trial (Stage 2 only)
* Patients not prescribed 78Gy in 39 fractions to the prostate gland.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00890006
Study Brief:
Protocol Section:
NCT00890006