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Application of 18F-PSMA-1007 PET/CT in Patients with Newly Diagnosed and Recurrent Prostate Cancer

Application of 18F-PSMA-1007 PET/CT in Patients with Newly Diagnosed and Recurrent Prostate Cancer: A Prospective, Diagnostic Clinical Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112856
Enrollment
Unknown
Registered
2025-11-20
Start date
2024-07-02
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Prostate cancer is a common cancer in men that originates in the prostate gland and often has no obvious symptoms in the early stages. As the disease progresses, urinary symptoms such as frequent urination, urgent need to urinate, and difficulty or pain during urination may occur, along with decreased sexual function, such as erectile dysfunction, as well as other symptoms like bone pain and weigh

Interventions

Index test:Equipment: PET/CT Tracer: PSMA

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old and =0.2ng/mL; 4. After radical radiotherapy (as defined by the ASTRO-Phoenix consensus) : PSA increases by >=2ng/mL from the minimum value. 5.Karnofsky physical condition >=60 (or ECOG/WHO equivalent score). 6. Blood routine: WBC>=4×10^9/L, Platelet>=100×10^9/L, Hb>=90g/L. 7. Liver function: ALT, AST, ALP, TBil=28g/L. 8. Renal function: Creatinine clearance rate >=30ml/min. 9. The expected survival time exceeds 12 months. 10. Agree to strict contraception for at least 28 days after administration of 18F-PSMA-11. 11. Be willing and able to abide by planned visits, diagnostic plans, clinical laboratory tests and other trial procedures.

Exclusion criteria

Exclusion criteria: 1.History of any other malignancies in the past year, except for non-metastatic basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and superficial bladder cancer. 2.Previous use of radioactive isotopes with a time interval of less than 10 physical half-lives from the time of study drug administration. 3.Currently participating or planning to participate in any clinical trials involving drugs or devices during the study period. 4.Known allergy to the active ingredient or components of 18F-PSMA-11. 5.Inability to lie flat or remain still during a PET scan, or intolerance to PET scanning. 6.Presence of abnormalities in physical examination, ECG, or clinical laboratory tests during the screening period that, in the investigator's judgment, may affect safety or adherence. 7.Those who, in the opinion of the investigator, should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Diagnostic sensitivity;Specificity;

Countries

China

Contacts

Public ContactQing Zhang;Qing Zhang

The First Affiliated Hospital of Nanchang University

10187476@qq.com+86 7918890889

Outcome results

None listed

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