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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT03675451
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed localized prostate cancer that are scheduled to undergo radical prostatectomy.
* Age \>18 years.
* Patients must have laboratory values consistent with eligibility to undergo a radical prostatectomy:
* creatinine less than or equal to 1.5 X upper limit of normal
* creatinine clearance \> 60 mL/min
* The effects of 89Zr-Df-IAB2M on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, 89Zr-Df-IAB2M PET/CT and the surgical resection used for the study evaluation.
* Transrectal prostate biopsy performed less than four weeks prior to 89Zr-Df-IAB2M administration.
* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03675451
Study Brief:
Protocol Section:
NCT03675451