Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Patients With Prostat… (NCT06922903) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Patients With Prostate Cancer.
China240 participantsStarted 2025-04
Plain-language summary
A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in patients with Prostate Cancer
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males aged ≥18 years old
. ECOG score of 0 or 1
. Participants confirmed as prostate adenocarcinoma by histological pathological diagnosis before surgery, and meets the diagnostic criteria for intermediate-risk and above localized prostate cancer in the 2023 CSCO (Chinese Society of Clinical Oncology) guidelines (clinical T stage ≥ T2b; or PSA \> 10 ng/mL; or Gleason \> 6 score)
. Intended to undergo radical prostatectomy accompanied by pelvic lymph node dissection
. Routine blood tests, liver and kidney function, and coagulation function meet the corresponding conditions:
. Life expectancy of at least 6 months as assessed by investigator
. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, and avoid sperm donation
. The participant/legal authorized representative understands the purpose and procedures of the trial and signs the informed consent form
Exclusion criteria
. Participants who are unable to complete the imaging as required
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
With the pathological diagnosis as the standard of truth, the sensitivity and specificity of INR101 injection PET/CT imaging in detecting pelvic lymph node metastasis at the participant level
. Having had ≥ 2 types of malignant tumors within 5 years prior to the first administration, with the exception of fully treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and superficial bladder cancer.
. Participants who have previously received, are currently receiving, or plan to receive (from the signing of the informed consent form until the acquisition of the pathological sample) androgen deprivation therapy or any anti-tumor therapy such as radiotherapy, chemotherapy, or endocrine therapy during the trial period.
. Participants in other interventional clinical trials and within 5 half-lives of the investigational medicinal product or participants in other interventional clinical trials before signing the informed consent form; or participants in clinical trials of radioactive therapeutic drugs before signing the informed consent form and the time from the drug withdrawal to the signing date of the informed consent form is less than 3 months.
. Have received intravenous iodine contrast agent within 24 hours prior to the administration of INR101, or have received any high-density oral contrast agent within 5 days (except for those who, as judged by the investigator, have no residual contrast agent in the intestines; oral water-soluble contrast agents are acceptable).
. Participants with a history of salivary gland diseases or Paget's disease
. Participants with hip joint prostheses
. Known allergy to the active ingredients of INR101 or its components