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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT02290561
Eligibility Criteria:
Inclusion Criteria:
1. Histological diagnosis of prostate cancer (PSA \</=15ng/ml, Gleason score \</=4+3, and radiological stage \</=T3aNoMo)
2. Prostate biopsy concordant with mpMRI lesion (template transperineal or MRI-targeted biopsy only)
3. Discrete lesion on mpMRI scoring 3, 4 or 5 on radiological scale of suspicion
4. mpMRI carried out according to European Society of Uro-Radiology guidelines at 1.5T or 3T
5. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
6. Signed informed consent
Exclusion Criteria:
1. No lesion on mpMRI
2. Bilateral lesions on mpMRI
3. mpMRI undertaken over 6 months prior to visit 1
4. Contralateral Gleason \>/=3+4 and/or Maximum Cancer Core Length Involvement \>/=6mm
5. Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
6. Prior immunosuppression or predefined immunosuppressed state
7. An irreversible coagulopathy predisposing to bleeding
8. Unable to undergo transrectal ultrasonography
9. Previous radiation therapy to the pelvis
10. Previous HIFU, cryosurgery, thermal, irreversible electroporation, radiofrequency or microwave therapy to the prostate.
11. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
12. Men not fit for major surgery as assessed by a consultant anaesthetist
13. Men who are unable to give informed consent
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02290561
Study Brief:
Protocol Section:
NCT02290561