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Clinical Application Study of the PSMA-XJ-215 Molecular Probe for Imaging Diagnosis of Prostate Cancer

Clinical Application Research of 68Ga-DOTA-PSMA-215 Molecular Probe in Prostate Cancer Imaging Diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109505
Enrollment
Unknown
Registered
2025-09-19
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

Gold Standard:The gold standard is the postoperative pathological result, with the specific criteria based on The International Society of Urological Pathology (ISUP) Consensus on Prostate Cancer Grad
Index test:The PSMA-targeted molecular probe 68Ga-DOTA-PSMA-215

Sponsors

Xijing Hospital, Airforce Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Patients: 1. Patients diagnosed with T1-4NxM0 prostate cancer; 2. Scheduled to undergo radical prostatectomy; 3. Male patients aged between 40 and 80 years (inclusive); 4. Life expectancy of more than 12 months as judged by the doctor; 5. Patients and their family members fully understand the patient’s condition and the options of treatment plans, and sign the informed consent form for voluntary participation in the clinical trial.

Exclusion criteria

Exclusion criteria: 1. A history of any previous prostate cancer treatment; 2. Patients with other types of malignant tumors in addition to prostate cancer; 3. Patients with severe pelvic diseases that affect or restrict surgical procedures; 4. Inability to tolerate PET and other imaging examinations (e.g., claustrophobia, radiophobia); 5. Inability to tolerate radical prostatectomy; 6. Severe diseases of the heart, kidneys, lungs, blood vessels, nervous system, or mental health system, as well as immunodeficiency diseases, hepatitis, or liver cirrhosis; 7. Participation in other interventional clinical trials within 1 month prior to screening; 8. Patients currently receiving chemotherapy, immunotherapy, or molecular targeted therapy; 9. Patients who refuse to sign the informed consent form or are unable to cooperate with the study; 10. Other circumstances deemed by the researcher to make the patient unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
The diagnostic accuracy of the imaging signals (positive or negative) of prostate cancer lesions for the postoperative histopathological results (positive or negative) of prostate cancer lesions;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactQin weijun; Kang Fei

Xijing Hospital, Airforce Medical University

qinwj@fmmu.edu.cn+86 29 8477 1082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026