A Multicenter, Open-label, Prospective Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Participants With Suspected Recurrent Prostate Cancer After Radical Treatment

Launched by YUNHE PHARMACEUTICAL (TIANJIN) CO., LTD · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called INR101, which is being evaluated for use in PET/CT imaging to help identify if prostate cancer has returned in men who have already been treated. This trial is specifically aimed at men aged 18 and older who have been diagnosed with prostate cancer and have an elevated PSA level, indicating a possible recurrence after treatment like surgery or radiation. To participate, men must also be in good overall health and have a life expectancy of at least six months.

If eligible and you choose to participate, you will receive the INR101 injection and undergo imaging tests to see how well the injection works in detecting cancer. It’s important to know that this trial is not yet recruiting participants, and anyone interested will need to meet specific health criteria. The study is designed to ensure safety and effectiveness, so potential participants will be carefully screened for any conditions that might affect the trial results.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Males aged ≥18 years old
• • 2. ECOG score of 0 or 1
• • 3. Participants confirmed as prostate adenocarcinoma by histological pathological diagnosis, and have an elevated PSA level and are suspected of recurrence after previously receiving radical prostatectomy and/or radical radiotherapy (the PSA level is ≥ 0.2 ng/mL in two consecutive tests after 6 weeks following radical prostatectomy; or the PSA level is increased by ≥ 2 ng/mL compared to the lowest value after radical radiotherapy).
• 4. Routine blood tests, liver and kidney function meet the corresponding conditions:
• • Hemoglobin \> 80 g/L; Platelet count \> 50×10⁹/L
• • AST, ALT≤ 5 x ULN
• • Total bilirubin≤ 3 x ULN
• • 5. Life expectancy of at least 6 months as assessed by investigator
• • 6. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, and avoid sperm donation
• • 7. The participant/legal authorized representative understands the purpose and procedures of the trial and signs the informed consent form
• Exclusion Criteria:
• • 1. Participants who are unable to complete the imaging as required
• • 2. 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.
• • 3. 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.
• • 4. 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).
• • 5. Participants with a history of salivary gland diseases or Paget's disease; participants with a history of fracture within the past year
• • 6. Participants with hip joint prostheses
• • 7. Known allergy to the active ingredients of INR101 or its components
• • 8. Investigators judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.