Medullary Thyroid CarcinomaPhase 3CAST-MTCNCT07383246
CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
A Phase 3 study testing 68Ga-CTR-FAPI PET-CT guided surgery and investigator choice of surgery in people with Medullary Thyroid Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label, non-inferiority Phase III clinical trial, aims to compare 68Ga-CTR-FAPI PET-CT-guided surgery to investigator-chosen surgical approaches to evaluate its efficacy in treating newly diagnosed medullary thyroid carcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medullary Thyroid Carcinoma
- What is being tested?
- 68Ga-CTR-FAPI PET-CT guided surgery and investigator choice of surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2025to 31 Dec 2031
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:
- Pathologically or cytologically confirmed diagnosis;
- Elevated serum calcitonin level (>10 pg/mL);
- Other infectious or neoplastic diseases excluded.
- Life expectancy ≥ 12 weeks;
- ECOG performance status of 0 or 1;
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- Absence of distant metastasis confirmed by conventional imaging, with resectable locoregional disease;
- Scheduled to undergo surgery within 30 days;
- Females of childbearing potential must use effective contraception (e.g., sterilization, intrauterine device, condoms, oral/injectable contraceptives, abstinence, or partner vasectomy) during the study and for 6 months after study completion. Male participants must agree to use effective contraception during the same period;
- Capable of understanding and voluntarily signing the informed consent form with good compliance.
Who cannot join
- History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy).
- Major organ dysfunction, defined as:
- Bone marrow impairment: WBC ≤ 4.0×10⁹/L or neutrophils ≤ 1.5×10⁹/L; platelets ≤ 100×10⁹/L; hemoglobin ≤ 90 g/L
- Hepatic impairment: PT or APTT ≥ 1.5 × ULN; total bilirubin ≥ 1.5 × ULN; ALT/AST ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with liver metastases); ALP ≥ 2.5 × ULN (or ≥ 4.5 × ULN in cases with bone or liver metastases)
- Renal impairment: BUN ≥ 1.5 × ULN; serum creatinine ≥ 1.5 × ULN
- Women who are planning pregnancy, currently pregnant, or breastfeeding.
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- History of other malignant tumors;
- Inability to lie flat for at least 30 minutes;
- Known allergy to contrast agents;
- Claustrophobia or other psychiatric disorders that may preclude compliance with study procedures;
- Unwillingness to participate in the clinical trial;
- Assessed as not being a surgical candidate or refusal to undergo surgery;
- Any other condition deemed by the investigator to make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 10005
1342632919, nydd1998@163.com
About this study
Official title: 68Ga-CTR-FAPI PET-CT-guided Precision Surgery for Newly Diagnosed Medullary Thyroid Carcinoma: A Multicenter, Open-labeled, Randomized Controlled Phase 3 Trial
This is a multicenter, randomized, open-label, non-inferiority Phase III clinical trial, aims to compare 68Ga-CTR-FAPI PET-CT-guided surgery to investigator-chosen surgical approaches to evaluate its efficacy in treating newly diagnosed medullary thyroid carcinoma. This study plans to enroll 150 newly diagnosed MTC patients, who will be randomly assigned in a 2:1 ratio to the experimental group (surgery based on 68Ga-CTR-FAPI PET-CT findings) and the control group (surgery based on the investigator's choice). The primary endpoint is the biochemical cure rate, with secondary endpoints including the biochemical cure rate in the R0 resection subgroup, the unnecessary dissection rate in the biochemical-cured subgroup, 3-year recurrence-free survival, the rate of change in surgical extent, and diagnostic accuracy.
Read the detailed description
Medullary thyroid carcinoma (MTC) is a relatively difficult-to-treat malignant thyroid tumor with a wide range of metastases. Surgery is the only curative treatment, and accurate assessment of the extent of metastatic disease is crucial for planning the surgical extent. Conventional imaging modalities have limited utility in fully evaluating the extent of MTC involvement. The tumor microenvironment of MTC is rich in cancer-associated fibroblasts (CAFs), which highly express fibroblast activation protein (FAP), whereas normal tissue fibroblasts express little to no FAP. Given the co-localization relationship between MTC cells and CAFs, fibroblast activation protein inhibitors (FAPIs) targeting FAP can be used to localize MTC lesions. The molecular probe CTR-FAPI, developed through covalent modification, improved the detection rate and diagnostic accuracy for MTC, providing a theoretical basis for performing precise surgery for MTC based on the extent of disease revealed by 68Ga-CTR-FAPI PET-CT.
This is a multicenter, randomized, open-label, two-arm, non-inferiority Phase III clinical trial. This study plans to enroll 150 newly diagnosed MTC patients, who will be randomly assigned in a 2:1 ratio to the experimental group (surgery based on 68Ga-CTR-FAPI PET-CT findings) and the control group (surgery based on the investigator's choice).
The study hypothesizes that CTR-FAPI-guided surgery can identify and resect more positive lesions while avoiding prophylactic dissection of disease-free areas, thereby benefiting patients. Proving the benefit of the former requires complete resection of all positive lesions. However, due to the frequent local invasion and adhesions associated with MTC lesions, achieving R0 resection is difficult in some patients. Therefore, the primary objective is to demonstrate that CTR-FAPI-guided surgery is non-inferior to the investigator's choice in IIT population. The primary endpoint was biochemical cure rate at 1-month post-surgery, defined by normalization of serum calcitonin levels. This parameter represents the strictest curative level for MTC and correlates with survival outcomes. In a nationwide retrospective analysis involving 863 patients, the 10-year overall survival (OS) of biochemical-cured MTC was 97.7%; in comparison, the 10-year OS of non-cured MTC was 70.3%.
The secondary objectives are to demonstrate its superiority in the subgroup achieving R0 resection, and to show that it avoids unnecessary lateral neck/upper mediastinum dissection in the subgroup achieving biochemical-cure. Key secondary endpoints include: the biochemical cure rate at 1 month post-surgery in the R0 resection subgroup, and the unnecessary dissection rate in the biochemical-cured subgroup, which address the two important secondary objectives and the study hypothesis. Other secondary endpoints include: 3-year recurrence-free survival, the rate of surgical plan modification in the experimental group, and the diagnostic accuracy of different imaging modalities for MTC lesions.
- Conditions
- Medullary Thyroid Carcinoma
- Being tested
- 68Ga-CTR-FAPI PET-CT guided surgery, investigator choice of surgery
- Keywords
- Medullary Thyroid Cariconma, Surgery, CTR-FAPI
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-CTR-FAPI PET-CT guided surgeryProcedure or surgery
The participant will be intravenously administered with [68Ga]Ga-CTR-FAPI and undergo PET-CT imaging.The surgical extent will be determined by [68Ga]Ga-CTR-FAPI PET-CT image. The minimum extent of resection is total thyroidectomy plus central neck dissection. Therapeutic dissection of the lateral neck compartment and upper mediastinal lymph nodes within standard boundaries is performed, with the extent determined based on CTR-FAPI findings.
investigator choice of surgeryProcedure or surgery
Since there is currently no standardized surgical extent for medullary thyroid carcinoma, the surgical approach for the control group will be determined by the attending surgeon. Including but not limited to: Surgery based on conventional imaging (ultrasound/CT); Prophylactic neck dissection; Surgery based on tumor size, germline RET mutation status, and state of central lymph node metastasis; Surgery based on intraoperative frozen section findings.
| Study group | Role | What they receive |
|---|---|---|
| ⁶⁸Ga-CTR-FAPI PET-CT guided surgery | Experimental | The participants assigned to the experimental arm will undergo ⁶⁸Ga-CTR-FAPI PET-CT imaging.
The surgical extent will be determined by ⁶⁸Ga-CTR-FAPI PET-CT image. Receives: Procedure: 68Ga-CTR-FAPI PET-CT guided surgery |
| investigator choice of surgery | Active comparator | Since there is currently no standardized surgical extent for medullary thyroid carcinoma, the surgical approach for the control group will be determined by the attending surgeon, based on routine preoperative evaluation. Receives: Procedure: investigator choice of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical cure rate
Biochemical cure is defined as postoperative serum calcitonin level less than 10pg/ml
Measured: 1 month after surgery
Secondary outcomes (5)
Biochemical cure rate in R0 resection subgroup
Biochemical cure is defined as postoperative serum calcitonin level less than 10pg/ml. The outcome is assessed in the R0 resecton subgroup.
Measured: 1 month after surgery
Unnecessary dissection rate in the biochemical cured subgroup
The unnecessary dissection rate is defined as the proportion of patients whose dissections outside the central compartment yield no metastatic lymph nodes. This outcome will be evaluated exclusively in the biochemically cured subgroup, as only surgeries that achieve biochemical cure are considered to have an adequate surgical extent. In these patients, any dissection that yields negative specimens is deemed unnecessary. We anticipate that CTR-FAPI imaging will enable precise surgical planning, allowing for a more reduced extent of dissection compared to prophylactic surgery, thus minimizing complications.
Measured: 1month after surgery (after pathogoly report issued)
Recurrence-free survival
Recurrence-free survival is defined as the peroid from the date of surgery until any recurrence revealed by structural imaging or any cause of death. The day of imaging examination will be regarded as the day of recurrence.
Measured: 3 years after surgery
Change rate in the extent of surgery in the experimental arm
Change rate in the extent of surgery compared to the investigator's chioce in the experimental arm. The investigator's chosen surgical extent will be documented preoperatively when the attending doctor is not exposed to the CTR-FAPI findings.
Measured: immedaite after surgery
Diagnostic accuracy rate
Diagnostic accuracy is defined as the proportion of correctly diagnosed lesions (including both positive and negative) to the total number of lesions documented. It will be calculated separately for different imaging modalities (CTR-FAPI PET-CT, ultrasound, and CT).
Measured: 1 month after surgery (after pathology report issued)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start25 Aug 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medullary Thyroid CarcinomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Peking University First Hospital, Xiangya Hospital of Central South University, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
- Responsible party
- Principal investigator, SHAOYAN LIU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Shaoyan Liu, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383246
- Sponsor's protocol ID
- CAST-MTC-01
- Acronym
- CAST-MTC
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong Z, Li Z, Cui XY, Wang J, Xu M, Liu Y, Chen J, Ni S, Zhang Z, Fan X, Huang J, Lin Y, Sun Y, He Y, Lin X, Meng T, Li H, Song Y, Peng B, An C, Gao C, Li N, Liu C, Zhu Y, Yang Z, Liu Z, Liu S. CTR-FAPI PET Enables Precision Management of Medullary Thyroid Carcinoma. Cancer Discov. 2025 Feb 7;15(2):316-328. doi: 10.1158/2159-8290.CD-24-0897.
PubMed 39470165Cui XY, Li Z, Kong Z, Liu Y, Meng H, Wen Z, Wang C, Chen J, Xu M, Li Y, Gao J, Zhu W, Hao Z, Huo L, Liu S, Yang Z, Liu Z. Covalent targeted radioligands potentiate radionuclide therapy. Nature. 2024 Jun;630(8015):206-213. doi: 10.1038/s41586-024-07461-6. Epub 2024 May 22.
PubMed 38778111
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-CTR-FAPI PET-CT-guided Precision Surgery for Newly Diagnosed Medullary Thyroid Carcinoma: A Multicenter, Open-labeled, Randomized Controlled Phase 3 Trial
- ClinicalTrials.gov ID
- NCT07383246
- Acronym / sponsor ID
- CAST-MTC / CAST-MTC-01
- Conditions
- Medullary Thyroid Carcinoma
- Keywords
- Medullary Thyroid Cariconma, Surgery, CTR-FAPI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Peking University First Hospital, Xiangya Hospital of Central South University, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 3 Feb 2026 (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.
This is a multicenter, randomized, open-label, non-inferiority Phase III clinical trial, aims to compare 68Ga-CTR-FAPI PET-CT-guided surgery to investigator-chosen surgical approaches to evaluate its efficacy in treating newly diagnosed medullary thyroid carcinoma. This study plans to enroll 150 newly diagnosed MTC patients, who will be randomly assigned in a 2:1 ratio to the experimental group (surgery based on 68Ga-CTR-FAPI PET-CT findings) and the control group (surgery based on the investigator's choice). The primary endpoint is the biochemical cure rate, with secondary endpoints including the biochemical cure rate in the R0 resection subgroup, the unnecessary dissection rate in the biochemical-cured subgroup, 3-year recurrence-free survival, the rate of change in surgical extent, and diagnostic accuracy.
Detailed description
Medullary thyroid carcinoma (MTC) is a relatively difficult-to-treat malignant thyroid tumor with a wide range of metastases. Surgery is the only curative treatment, and accurate assessment of the extent of metastatic disease is crucial for planning the surgical extent. Conventional imaging modalities have limited utility in fully evaluating the extent of MTC involvement. The tumor microenvironment of MTC is rich in cancer-associated fibroblasts (CAFs), which highly express fibroblast activation protein (FAP), whereas normal tissue fibroblasts express little to no FAP. Given the co-localization relationship between MTC cells and CAFs, fibroblast activation protein inhibitors (FAPIs) targeting FAP can be used to localize MTC lesions. The molecular probe CTR-FAPI, developed through covalent modification, improved the detection rate and diagnostic accuracy for MTC, providing a theoretical basis for performing precise surgery for MTC based on the extent of disease revealed by 68Ga-CTR-FAPI PET-CT.
This is a multicenter, randomized, open-label, two-arm, non-inferiority Phase III clinical trial. This study plans to enroll 150 newly diagnosed MTC patients, who will be randomly assigned in a 2:1 ratio to the experimental group (surgery based on 68Ga-CTR-FAPI PET-CT findings) and the control group (surgery based on the investigator's choice).
The study hypothesizes that CTR-FAPI-guided surgery can identify and resect more positive lesions while avoiding prophylactic dissection of disease-free areas, thereby benefiting patients. Proving the benefit of the former requires complete resection of all positive lesions. However, due to the frequent local invasion and adhesions associated with MTC lesions, achieving R0 resection is difficult in some patients. Therefore, the primary objective is to demonstrate that CTR-FAPI-guided surgery is non-inferior to the investigator's choice in IIT population. The primary endpoint was biochemical cure rate at 1-month post-surgery, defined by normalization of serum calcitonin levels. This parameter represents the strictest curative level for MTC and correlates with survival outcomes. In a nationwide retrospective analysis involving 863 patients, the 10-year overall survival (OS) of biochemical-cured MTC was 97.7%; in comparison, the 10-year OS of non-cured MTC was 70.3%.
The secondary objectives are to demonstrate its superiority in the subgroup achieving R0 resection, and to show that it avoids unnecessary lateral neck/upper mediastinum dissection in the subgroup achieving biochemical-cure. Key secondary endpoints include: the biochemical cure rate at 1 month post-surgery in the R0 resection subgroup, and the unnecessary dissection rate in the biochemical-cured subgroup, which address the two important secondary objectives and the study hypothesis. Other secondary endpoints include: 3-year recurrence-free survival, the rate of surgical plan modification in the experimental group, and the diagnostic accuracy of different imaging modalities for MTC lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ⁶⁸Ga-CTR-FAPI PET-CT guided surgery | Experimental | Procedure: 68Ga-CTR-FAPI PET-CT guided surgeryThe participants assigned to the experimental arm will undergo ⁶⁸Ga-CTR-FAPI PET-CT imaging. The surgical extent will be determined by ⁶⁸Ga-CTR-FAPI PET-CT image. |
| investigator choice of surgery | Active comparator | Procedure: investigator choice of surgerySince there is currently no standardized surgical extent for medullary thyroid carcinoma, the surgical approach for the control group will be determined by the attending surgeon, based on routine preoperative evaluation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:
- Life expectancy ≥ 12 weeks;
- ECOG performance status of 0 or 1;
- Absence of distant metastasis confirmed by conventional imaging, with resectable locoregional disease;
- Scheduled to undergo surgery within 30 days;
Key exclusion criteria (13 listed)
- History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or interventional therapy).
- Major organ dysfunction, defined as:
- Women who are planning pregnancy, currently pregnant, or breastfeeding.
- History of other malignant tumors;
- Inability to lie flat for at least 30 minutes;
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 |
|---|---|---|
| 68Ga-CTR-FAPI PET-CT guided surgeryThe participant will be intravenously administered with [68Ga]Ga-CTR-FAPI and undergo PET-CT imaging.The surgical extent will be determined by [68Ga]Ga-CTR-FAPI PET-CT image. The minimum extent of resection is total thyroidectomy plus central neck dissection. Therapeutic dissection of the lateral neck compartment and upper mediastinal lymph nodes within standard boundaries is performed, with the extent determined based on CTR-FAPI findings. | Procedure or surgery | ⁶⁸Ga-CTR-FAPI PET-CT guided surgery |
| investigator choice of surgerySince there is currently no standardized surgical extent for medullary thyroid carcinoma, the surgical approach for the control group will be determined by the attending surgeon. Including but not limited to: Surgery based on conventional imaging (ultrasound/CT); Prophylactic neck dissection; Surgery based on tumor size, germline RET mutation status, and state of central lymph node metastasis; Surgery based on intraoperative frozen section findings. | Procedure or surgery | investigator choice of surgery |
Primary outcome
Biochemical cure rate
Time frame: 1 month after surgery
Biochemical cure is defined as postoperative serum calcitonin level less than 10pg/ml
5 secondary outcomes
Biochemical cure rate in R0 resection subgroup
Time frame: 1 month after surgery
Unnecessary dissection rate in the biochemical cured subgroup
Time frame: 1month after surgery (after pathogoly report issued)
Recurrence-free survival
Time frame: 3 years after surgery
Change rate in the extent of surgery in the experimental arm
Time frame: immedaite after surgery
Diagnostic accuracy rate
Time frame: 1 month after surgery (after pathology report issued)
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 3 Feb 2026.
- Results publication: PubMed 39470165Kong Z, Li Z, Cui XY, Wang J, Xu M, Liu Y, Chen J, Ni S, Zhang Z, Fan X, Huang J, Lin Y, Sun Y, He Y, Lin X, Meng T, Li H, Song Y, Peng B, An C, Gao C, Li N, Liu C, Zhu Y, Yang Z, Liu Z, Liu S. CTR-FAPI PET Enables Precision Management of Medullary Thyroid Carcinoma. Cancer Discov. 2025 Feb 7;15(2):316-328. doi: 10.1158/2159-8290.CD-24-0897.
- Results publication: PubMed 38778111Cui XY, Li Z, Kong Z, Liu Y, Meng H, Wen Z, Wang C, Chen J, Xu M, Li Y, Gao J, Zhu W, Hao Z, Huo L, Liu S, Yang Z, Liu Z. Covalent targeted radioligands potentiate radionuclide therapy. Nature. 2024 Jun;630(8015):206-213. doi: 10.1038/s41586-024-07461-6. Epub 2024 May 22.
- 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.
Shaoyan Liu, MD principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga-CTR-FAPI PET-CT guided surgery and investigator choice of surgery in people with Medullary Thyroid Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site 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 13 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ziren Kong, MD (0086-18500487274, kongziren@pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical cure rate (time frame: 1 month after surgery). 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 NCT07383246, which also lists 2 linked publications.
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 3 Feb 2026.