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
- Registration Number
- NCT06922929
- Lead Sponsor
- Yunhe Pharmaceutical (Tianjin) Co., Ltd
- Brief Summary
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.
- Detailed Description
This is a prospective, multicenter, open-label, single-arm, non-randomized Phase III clinical trial evaluating the diagnostic efficacy and safety of INR101 injection PET/CT imaging in participants with suspected recurrence prostate cancer, who have experienced an increase in PSA levels after previously receiving radical treatment.
Participants enrolled in clinical trial will receive a single intravenous injection of INR101 injection at a dose of 7 mCi ± 15%, and PET/CT imaging will be performed 80 to 120 minutes after the injection.
The PET/CT images of INR101 injection for each participant will be interpreted independently by two readers blinded to all participant information. When the conclusions of the two readers are inconsistent, a third reader will be added for an adjudication interpretation (the third reader will also be in a blinded during the interpretation process and shall not be aware of the conclusions of the first two readers).
This study adopts a composite diagnostic criterion as the standard of truth. The interpretation of the composite diagnostic criterion is as follows: If a pathological diagnosis can be obtained, the pathological diagnosis shall be regarded as the standard of truth; if a pathological diagnosis cannot be obtained, a comprehensive interpretation shall be made based on the participant's medical history, changes in PSA levels and the results of conventional imaging examinations. The interpretation of the composite diagnostic criterion for each participant will be interpreted independently by two readers. When the conclusions of the two readers are inconsistent, a third reader will be added for an adjudication interpretation.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 110
-
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).
-
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
-
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
- 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).
- Participants with a history of salivary gland diseases or Paget's disease; participants with a history of fracture within the past year
- Participants with hip joint prostheses
- Known allergy to the active ingredients of INR101 or its components
- Investigators judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description INR101 PET/ CT INR101 Drug: INR101 7±15% mCi of INR101 will be injected intravenously prior to perform the PET/CT
- Primary Outcome Measures
Name Time Method 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 3~12 months after administration 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
- Secondary Outcome Measures
Name Time Method 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 3~12 months after administration 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 3~12 months after administration 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
Assess the consistency of the diagnosis of PET/CT images intra- and inter-reader 3~12 months after administration The intra- and inter-reader performance will be evaluated by adjudication rate and accept rate
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 3~12 months after administration 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 3~12 months after administration 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
Evaluate the safety and tolerability, including adverse events (AE)/serious adverse events (SAE), vital signs, physical examinations, laboratory tests and 12-lead electrocardiograms 7 days after administration Adverse events will be determined through clinical assessment and categorized by CTCAE 5.0
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (32)
Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing GoBroad Hospital
🇨🇳Beijing, Beijing, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Wuhan Central Hospital
🇨🇳Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Tianjin First Central Hospital
🇨🇳Tianjin, Tianjin, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
Tianjin Cancer Hospital Airport Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China