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Prostate CancerPhase 3NCT06922903

Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Patients With Prostate Cancer.

A Phase 3 study testing INR101 in people with Prostate Cancer, run by Yunhe Pharmaceutical (Tianjin) Co., Ltd at 32 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in patients with Prostate Cancer Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
INR101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
32 sitesChina
Study dates
Apr 2025to May 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dong Yuan contact

+86-18611999529

yuandong@ynby.cn

Lianlian Li contact

+86-18210596337

lilianlian@ynby.cn

32 sites in 1 country

China32 sites

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100144

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 102206

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061001

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Taizhou People's Hospital

    Taizhou, Jiangsu, 225300

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300192

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300308

  • Wuhan Central Hospital

    Wuhan, Hubei, 430014

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

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei, 430030

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

Other trials in China

About this study

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

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

Read the 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).

Conditions
Prostate Cancer
Being tested
INR101
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INR101Drug

    INR101

Study groups in NCT06922903
Study groupRoleWhat they receive
INR101 PET/ CTExperimentalDrug: INR101 7±15% mCi of INR101 will be injected intravenously prior to perform the PET/CT
Receives: Drug: INR101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days after administration

Secondary outcomes (4)

  1. 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

    The positive predictive value, negative predictive value and accuracy of the participant -level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against histopathology

    Measured: 30 days after administration

  2. 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

    The detection rate of distant metastatic lesions (lymph nodes outside the pelvis, viscera/soft tissues and bones) will be determined of INR101 injection PET/CT imaging for detection of lesion, comparing with conventional imaging

    Measured: 30 days after administration

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

    The intra- and inter-reader performance will be evaluated by adjudication rate and accept rate

    Measured: 30 days after administration

  4. Evaluate the safety and tolerability, including adverse events (AE)/serious adverse events (SAE), vital signs, physical examinations, laboratory tests and 12-lead electrocardiograms

    Adverse events will be determined through clinical assessment and categorized by CTCAE 5.0

    Measured: 7 days after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06922903
Sponsor's protocol ID
INR101-III-02
Other IDs
CTR20250775
Status last verified
Apr 2025
First submitted
3 Apr 2025
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INR101 in people with Prostate Cancer, run by Yunhe Pharmaceutical (Tianjin) Co., Ltd at 32 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong Yuan (+86-18611999529, yuandong@ynby.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 30 days after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06922903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

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