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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07415135
Eligibility Criteria:
Inclusion Criteria:
* Subjects with pathologically confirmed prostate cancer via preoperative prostate core needle biopsy who are scheduled to undergo robot-assisted radical prostatectomy (RARP).
* Subjects must provide informed consent for the trial prior to enrollment, with a full understanding of the trial content, procedures and potential adverse events; they must be able to communicate effectively with investigators, comply with the trial protocol to complete the entire study, and voluntarily sign a written informed consent form.
* Male adult subjects aged 18 years or older (inclusive).
* Gleason total score ≥7, or radiological findings (transrectal ultrasound (TRUS) and/or prostate magnetic resonance imaging (MRI), computed tomography (CT) or prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT)) indicating clinical stage ≥T2.
* No hepatic or renal impairment: Hepatic function: Total bilirubin ≤2 × upper limit of normal (ULN) (except for Gilbert's syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN; Renal function: Creatinine clearance rate ≥50 mL/min/1.73 m² (calculated via the simplified MDRD equation).
* Subjects judged by the investigator to have no definite surgical contraindications and to be suitable for robot-assisted radical prostatectomy (RARP).
* Subjects and their partners/spouses must agree to have no childbearing or sperm donation plans from the screening period to 3 months after the trial completion, and voluntarily adopt effective contraceptive measures.
Exclusion Criteria:
* Subjects with an allergic diathesis (e.g., a known history of hypersensitivity to two or more drugs), a predisposition to allergic symptoms such as rashes or urticaria, or a known hypersensitivity to the study drug (including its ingredients).
* Subjects with clinically significant abnormal findings in screening tests that are judged by the investigator to affect the study; or those with comorbidities that pose a serious risk to subject safety or interfere with study completion (except for subjects whose conditions are judged by the investigator to be stable for enrollment).
* Subjects who have participated in other clinical trials and received investigational drugs or medical devices within 1 month prior to the administration of the study drug.
* Subjects who have received neoadjuvant therapy, radiotherapy, focal ablation therapy, hormonal therapy, androgen deprivation therapy, or other such treatments in the past 6 months.
* Subjects who are judged by the investigator to be ineligible for the study due to other circumstances.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07415135
Study Brief:
Protocol Section:
NCT07415135