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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT02623933
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate
2. Low and Intermediate risk disease defined as T1-T2c, Gleason \< 7 and PSA \< 20 ng/ml.
3. Prostate volume \< 60 cc as determined by US, CT or MRI
4. Ability to undergo MR imaging
5. Provide written informed consent
6. Identified MR nodule (PIRADs 4/5)
Exclusion Criteria:
1. Ineligible for MR imaging due to contraindications
2. Documented nodal or distant metastases
3. Previous pelvic radiotherapy
4. Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
5. Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
6. Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>15
7. Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
8. Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02623933
Study Brief:
Protocol Section:
NCT02623933