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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT04402151
Eligibility Criteria:
Inclusion Criteria:
* Male aged 21 years or older.
* Ability to provide signed informed consent and willingness to comply with protocol requirements.
* Pathologic confirmation of high-risk adenocarcinoma of the prostate gland as follows: a. Gleason 8-10 or tertiary component 5 disease and/or b. PSA of 20 ng/ml or greater and/or c. Tumor stage of T2c or greater; OR Unfavorable intermediate risk (Gleason 4+3=7, \>50% of cores involved, or 2 or more intermediate risk factors which include Gleason 7 disease, PSA 10-20, or T2b disease)
* Participants must agree to use an acceptable form of birth control and utilize condoms for a period of seven days after each PSMA injection, if engaged in sexual activity.
* No evidence of metastatic disease, including pelvic lymph nodes.
Exclusion Criteria:
* Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR.
* Contraindications to PSMA IV administration
* Contraindications to prostate SBRT (history of transurethral resection of prostate; prostate size greater than 150 cc; AUA score greater than 20; history of prior radiation to the prostate)
* Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
* Patients on or intending to take abiraterone will be excluded
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT04402151
Study Brief:
Protocol Section:
NCT04402151