Clinical trial NCT06922903: Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Patients With Prostate Cancer.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Yunhe Pharmaceutical (Tianjin) Co., Ltd
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in patients with Prostate Cancer

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 detecting the presence of pelvic lymph node metastasis in participants who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection.

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).

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 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)
4. Intended to undergo radical prostatectomy accompanied by pelvic lymph node dissection
5. 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.
6. Life expectancy of at least 6 months as assessed by investigator
7. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, and avoid sperm donation
8. 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 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.
4. 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.
5. 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).
6. Participants with a history of salivary gland diseases or Paget's disease
7. Participants with hip joint prostheses
8. Known allergy to the active ingredients of INR101 or its components
9. 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.)
10. Investigators judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.

Primary outcomes:
measure: 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
timeFrame: 30 days after administration
Secondary outcomes:
measure: 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
timeFrame: 30 days after administration
measure: 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
timeFrame: 30 days after administration
measure: Assess the consistency of the diagnosis of PET/CT images intra- and inter-reader
timeFrame: 30 days after administration
measure: Evaluate the safety and tolerability, including adverse events (AE)/serious adverse events (SAE), vital signs, physical examinations, laboratory tests and 12-lead electrocardiograms
timeFrame: 7 days after administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing GoBroad Hospital
state: Beijing
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Hongcheng Shi
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jianming Guo
role: PRINCIPAL_INVESTIGATOR
References: