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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT03439033
Eligibility Criteria:
1. Male aged 21 years or older.
2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
3. Pathologic confirmation of adenocarcinoma of the prostate gland or high clinical suspicion (PSA \> 4 ng/mL, or PSA density \> 0.15 ng/mL2, or PSA doubling time \< 2 years).
4. Meet one of the following 5 criteria
1. Planned for surgical extirpation, which may or may not include lymph node dissection (high risk primary disease)
2. Planned for targeted biopsy of primary lesion
3. Conventional imaging equivocal or suggestive of prostate cancer metastasis/es
4. Planned focal therapy (with or without radiation therapy) with serial follow-up
5. Elevated PSA with no conventional imaging suggestive of metastatic or recurrent disease
5. a. If part of PET/MRI cohort, subject will undergo clinically indicated MRI imaging prior to treatment.
Or b. If part of PET/CT cohort, subject will have had clinically indicated MRI within 3 months prior to treatment.
6. Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity.
Exclusion Criteria:
1. Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MRI.
2. If part of PET/MRI cohort and patient cohort 3 or 5, subject does not plan to have a prescribed abdomen and pelvis MRI
3. If part of PET/MRI cohort and patient cohort 1, 2 or 4, subject does not plan to have a prescribed pelvis MRI
4. If part of PET/CT cohort and patient cohort 3 or 5, subject does not have previous MR imaging of abdomen and pelvis
5. If part of PET/CT cohort and patient cohort 1, 2 or 4, subject does not have previous MR imaging of pelvis
6. If part of PET/CT cohort, investigator review determines that previous MR images do not meet institutional quality standards
7. If part of PET/MRI cohort, contraindications to MRI
8. Contraindications to PSMA IV administration
9. Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT03439033
Study Brief:
Protocol Section:
NCT03439033