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 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT03663218
Eligibility Criteria:
Inclusion Criteria:
* Men aged greater than equal to18 with histologically confirmed primary prostate cancer.
* KPS greater than equal to 70
* Patient with a negative staging bone scan.
* Patient can undergo an MRI.
* Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short axis. Documented negative biopsy of suspicious node required.
* Patient is medically fit to undergo prostatectomy.
* Patient has either Gleason Score greater than equal to 8 on biopsy and/or clinical/radiographic evidence of T3 disease.
Exclusion Criteria:
* Prior history of receiving pelvic radiotherapy.
* Patient is unwilling to undergo prostatectomy.
* Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03663218
Study Brief:
Protocol Section:
NCT03663218