Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Patients With Prostate Cancer.
A Multicenter, Open-label, Prospective Phase III Clinical Trial to Evaluate the Diagnostic Efficacy and Safety of INR101 Injection for PET/CT Imaging in Detecting Preoperative Pelvic Lymph Node Metastasis in Patients With Prostate Cancer
2 other identifiers
interventional
240
1 country
32
Brief Summary
A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in patients with Prostate Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
Started Apr 2025
Shorter than P25 for phase_3 prostate-cancer
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 3, 2025
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 13, 2025
April 1, 2025
1.1 years
April 3, 2025
April 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
The sensitivity and specificity of the participant-level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against histopathology
30 days after administration
Secondary Outcomes (4)
With pathological diagnosis as the standard of truth, other diagnostic efficacies of INR101 injection PET/CT imaging in detecting pelvic lymph node metastasis at the participant level, including positive predictive value, negative predictive value and ac
30 days after administration
Compared with conventional imaging examinations, evaluate the difference in the detection rate of distant metastatic lesions (lymph nodes outside the pelvis, viscera/soft tissues and bones) by INR101 injection PET/CT imaging
30 days after administration
Assess the consistency of the diagnosis of PET/CT images intra- and inter-reader
30 days after administration
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
Study Arms (1)
INR101 PET/ CT
EXPERIMENTALDrug: INR101 7±15% mCi of INR101 will be injected intravenously prior to perform the PET/CT
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Platelet count \> 100×10⁹/L.
- Blood urea nitrogen/urea and serum creatinine ≤ 1.5 x ULN.
- AST, ALT, and ALP ≤ 2.5 x ULN.
- Total bilirubin≤ 1.5 x ULN.
- PT and APTT≤ 1.5 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
You may not qualify if:
- 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 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
- Serum virology examination, including positive treponema pallidum antibody, positive HIV antibody, positive hepatitis C antibody with positive hepatitis C virus ribonucleic acid (HCV RNA), or active hepatitis B (for those with positive hepatitis B surface antigen, hepatitis B virus deoxyribonucleic acid (HBV DNA) needs to be detected, and if the HBV DNA is positive). (Note: If the investigator assesses and determines that active hepatitis B is not a contraindication for surgery, the participant may be enrolled in the study.)
- Investigators judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061001, China
Wuhan Central Hospital
Wuhan, Hubei, 430014, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300192, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongcheng Shi
Fudan University
- PRINCIPAL INVESTIGATOR
Jianming Guo
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2025
First Posted
April 11, 2025
Study Start
April 1, 2025
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
April 13, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share