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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT02280356
Eligibility Criteria:
Inclusion Criteria:
* Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
* Pathologically-proven diagnosis of prostate adenocarcinoma
* PSA 10-20ng/mL or
* Gleason =7 or
* Clinical stage T2b/c
* Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
* Age ≥18
* KPS≥70
* Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
* International Prostate Symptom Score ≤15
Exclusion Criteria:
* Prior prostate surgery (including TURP)
* Prior history of chronic prostatitis or urethral stricture
* Inflammatory bowel disease
* Prior history of pelvic radiotherapy
* Unable to give informed consent
* Metastatic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02280356
Study Brief:
Protocol Section:
NCT02280356