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.
Males aged ≥18 years old
ECOG score of 0 or 1
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).
Hemoglobin > 80 g/L; Platelet count > 50×10⁹/L
Participants who are unable to complete the imaging as required
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 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).
Single group
INR101
DrugINR101 PET/ CT
With the composite diagnostic criteria as the standard of truth, the positive predictive value (PPV) at the participant level by PET/CT imaging with INR101 injection of lesion detection
The positive predictive value (PPV) of the participant level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
With pathological diagnosis as the standard of truth, Correct Detection Rate (CDR), Correct Localization Rate (CLR) at the participant level by PET/CT imaging with INR101 injection of lesion detection
The Correct Detection Rate (CDR), Correct Localization Rate (CLR) of the participant level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
With pathological diagnosis as the standard of truth, the positive predictive value (PPV) at the regional level (prostate, pelvic lymph nodes, extra-pelvic lymph nodes, visceral/soft tissues, bone) by PET/CT imaging with INR101 injection of lesion detect
The positive predictive value (PPV) of the regional level (prostate, pelvic lymph nodes, extra-pelvic lymph nodes, visceral/soft tissues, bone) will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
In the group with negative baseline conventional imaging, the detection rate (DR), correct detection rate (CDR), and positive predictive value (PPV) at the participant level by PET/CT imaging with INR101 injection of lesion detection
The detection rate (DR), correct detection rate (CDR), and positive predictive value (PPV) of the participant level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
Among participants with different baseline PSA levels, the positive predictive value (PPV) at the participant level of PET/CT imaging with INR101 injection
The positive predictive value (PPV) will be evaluated on a per- participant basis, stratified by PSA values: 0.2\~0.5, 0.5\~1.0, 1.0 \~2.0, 2.0\~5.0, ≥5.0ng/mL
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