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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT02632669
Eligibility Criteria:
Inclusion Criteria:
1. TRUS biopsy (if taken):
unilateral disease only
2. Template biopsy (TTB):
unilateral disease only, AND Gleason \< 7 (either 3+4 or 4+3)
3. mp-MRI results: Disease must present as unilateral (left or right) only
4. Stage T1-T2bN0M0 disease, as determined by local guidelines \*
5. Serum PSA \< 15
6. Prostate volume \< 50cc
7. Eligible for brachytherapy as outlined in local guidelines\*
8. Life expectancy \> 10 years
Exclusion Criteria:
1. Men who have had previous radiation therapy
2. Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
3. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
* https://www.rcr.ac.uk/quality-assurance-practice-guidelines-transperineal-ldr-permanent-seed-brachytherapy-prostate-cancer
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02632669
Study Brief:
Protocol Section:
NCT02632669