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

NCT06922929 | Not Yet Recruiting Phase 3

• 2 other identifiers: INR101-III-01CTR20250776
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 32

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.

Conditions

Prostate Cancer Recurrent

Keywords

suspected recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

  3~12 months after administration

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• Assess the consistency of the diagnosis of PET/CT images intra- and inter-reader

  3~12 months after administration

Study Arms (1)

INR101 PET/ CT

EXPERIMENTAL

Drug: INR101 7±15% mCi of INR101 will be injected intravenously prior to perform the PET/CT

Drug: INR101

Interventions

INR101 DRUG

INR101 PET/ CT

INR101 PET/ CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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.

Sponsors & Collaborators

• Yunhe Pharmaceutical (Tianjin) Co., Ltd: lead

Study Sites (32)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, 061001, China

Location

Wuhan Central Hospital

Wuhan, Hubei, 430014, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Yichang Central People's Hospital

Yichang, Hubei, 443003, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Taizhou People's Hospital

Taizhou, Jiangsu, 225300, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Study Officials

• Hongcheng Shi

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jianming Guo

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Yuan

CONTACT

+86-18611999529; yuandong@ynby.cn

Lianlian Li

CONTACT

+86-18210596337; lilianlian@ynby.cn

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 (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (32)