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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT04832958
Eligibility Criteria:
Inclusion Criteria:
* Male patients
* Age between 18 and 80 years
* Biopsy proven PCa with a LNI risk \>5% according to the Briganti nomogram
* Planned to receive a RARP with an ePLND
* Able to understand and willing to sign a written informed consent document
Exclusion Criteria:
* Receipt of neoadjuvant therapies
* Inability to complete the imaging examinations according to the prospective protocol
* Evidence of metastatic disease at conventional imaging before surgery
* Evidence of clinical lymphadenopathies at conventional imaging before surgery
* Life expectancy of less than 12 months
* Previous chemotherapy
* Previous brachytherapy or external beam radiotherapy
* Unstable cardiovascular disease
* Congestive Heart Failure (CHF)
* Clinically significant hepatobiliary or renal disease
* History of significant CNS injuries within 6 months
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
* Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I\&S and 68Ga-PSMA)
* Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04832958
Study Brief:
Protocol Section:
NCT04832958