| NCT ID | NCT05672485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-01-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-01-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose: This study will take prostate specific membrane antigen (PSMA) as the targeting of radionuclide labeled molecular probe to explore the diagnostic efficacy of 99mTc-P137 radioactive probe in prostate cancer. Combining with SPECT/CT to optimize the imaging, image analysis and clinical diagnosis process of 99mTc-P137 probe, the aim of the study is to provide new methods and new means for the early detection, early diagnosis, accurate tumor staging, treatment decision and prognosis judgment of malignant tumor, and will provide scientific and clinical basis for the precise diagnosis and treatment of prostate cancer. Research objectives: To investigate the clinical translational application value of 99mTc-P137 molecular probe in accurate detection of prostate cancer lesions. Research design: A prospective study design will be used in this study. Patients meeting the inclusion criteria of this study will be analyzed with 99mTc-P137 SPECT/CT imaging. To evaluate the diagnostic and prognostic value of 99mTc-P137 nuclear medicine imaging in accurate detection of prostate cancer lesions, clinical surgical specimens and pathological diagnosis will be used as the gold standard. Study the population Indications: For patients with suspected prostate cancer who plan to undergo surgical resection or puncture biopsy after various examinations, the final pathological results can be obtained.
Eligibility Criteria
Inclusion Criteria: * patients age 18 or above; * highly suspicious for prostate cancer patients: 1) Serum PSA is significantly changed compared with before (PSA\<4.0ng/mL with annual change \>0.35ng/mL; or PSA \> 4.0ng/mL with annual change \> 0.75ng/mL); 2) First or second degree relatives have a history of prostate cancer; 3) Nuclear magnetic PI-RADS score ≥3 points; * the prostate biopsy or surgical pathology is diagnosed with prostate cancer; * available to provide clinical laboratory results (blood routine, biochemical and serum PSA) within one month before this study; At least two imaging examinations including CT, MRI, nuclear medicine (PET/CT or SPECT/CT), ultrasound and other imaging techniques; * Can complete the inspection autonomously; * voluntary and signed informed consent. Exclusion Criteria: * there are other malignant tumor history; * severe damage of liver and kidney function; * may not be able to obtain pathology or long-term follow-up results; * don't have access to relevant reference image data and clinical data; * difficult to cooperate.
Contact & Investigator
Rui Gao
STUDY CHAIR
First Affiliated Hospital Xi'an Jiaotong University
Frequently Asked Questions
Who can join the NCT05672485 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05672485 currently recruiting?
Yes, NCT05672485 is actively recruiting participants. Contact the research team at jacky_mg@xjtufh.edu.cn for enrollment information.
Where is the NCT05672485 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT05672485 clinical trial?
NCT05672485 is sponsored by First Affiliated Hospital Xi'an Jiaotong University. The principal investigator is Rui Gao at First Affiliated Hospital Xi'an Jiaotong University. The trial plans to enroll 40 participants.
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