Prostate Cancer RecurrentPhase 3NCT06922929
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
A Phase 3 study testing INR101 in people with Prostate Cancer Recurrent, run by Yunhe Pharmaceutical (Tianjin) Co., Ltd at 32 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- 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
- 110 participants
- Where
- 32 sitesChina
- Study dates
- Apr 2025to Apr 2027
- 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, 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
Show all 10Show fewer
- 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
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 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.
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
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
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 Participants With Suspected Recurrent Prostate Cancer After Radical Treatment
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.
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 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.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- INR101
- Keywords
- suspected recurrent prostate cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INR101Drug
INR101 PET/ CT
| Study group | Role | What they receive |
|---|---|---|
| INR101 PET/ CT | Experimental | Drug: 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.
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 3~12 months after administration
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: 3~12 months 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
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.
- First posted11 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunhe Pharmaceutical (Tianjin) Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongcheng Shi, Principal investigator, Fudan UniversityJianming Guo, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922929
- Sponsor's protocol ID
- INR101-III-01
- Other IDs
- CTR20250776
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Participants With Suspected Recurrent Prostate Cancer After Radical Treatment
- ClinicalTrials.gov ID
- NCT06922929
- Acronym / sponsor ID
- INR101-III-01
- Conditions
- Prostate Cancer Recurrent
- Keywords
- suspected recurrent prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Yunhe Pharmaceutical (Tianjin) Co., LtdUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INR101 PET/ CT | Experimental | Drug: INR101Drug: INR101 7±15% mCi of INR101 will be injected intravenously prior to perform the PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Life expectancy of at least 6 months as assessed by investigator
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INR101INR101 PET/ CT | Drug | INR101 PET/ CT |
Primary outcome
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
Time frame: 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
6 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3~12 months after administration
Assess the consistency of the diagnosis of PET/CT images intra- and inter-reader
Time frame: 3~12 months 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
Time frame: 7 days after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongcheng Shi principal investigator
Fudan University
Jianming Guo principal investigator
Fudan University
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INR101 in people with Prostate Cancer Recurrent, 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 10 inclusion and 8 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 11 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 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 (time frame: 3~12 months after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.