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Applications of PSMA PET/CT-guided targeted puncture in patients with an initial negtive prostate biopsy

Applications of PSMA PET/CT-guided targeted puncture in patients with an initial negtive prostate biopsy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047627
Enrollment
Unknown
Registered
2021-06-21
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

prostate tumor

Interventions

Gold Standard:Pathologic analysis of punctured biopsy
PET/CT-guided&#32
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prostate

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with negative random prostate biopsy under the guidance of previous transrectal ultrasound and continuous elevation of serum PSA (4ng/ml<=PSA<10ng/ml); 2. ECOG performance status score 0-2; 3. Main organ function: no obvious abnormality in liver, kidney, bone marrow, heart and other important organ functions; 4. There is no obvious abnormality in the electrocardiogram, or the abnormality has no clinical significance; 5. All enrolled subjects should take adequate barrier contraceptive measures throughout the treatment period and within 4 weeks after the end of treatment; 6. Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed prior to any trial process; 7. No other malignant tumor other than prostate cancer at the time of initial diagnosis; 8. Patients who have not received endocrine, surgery or radiotherapy and chemotherapy before.

Exclusion criteria

Exclusion criteria: 1. Abnormal blood coagulation mechanism; 2. Patients with acute urinary tract infection; 3. Those who are contraindicated in CT examination; 4. Incomplete collection of data and information; 5. Patients with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases or infections; 6. Patients who abuse alcohol or narcotic drugs, have a history of drug abuse, or have a history of mental illness; 7. Patients who cannot cooperate with the relevant examinations of this project and do not agree to sign the informed consent; 8. Patients with claustrophobia.

Design outcomes

Primary

MeasureTime frame
Pathological type of tumor;Age;Body Mass Index;Maximal standard uptake value;Mean standard uptake value;Number of positive needles;Proportion of tumor;Gleason score;Prostate specific antigen;

Countries

China

Contacts

Public ContactXu Ning

The First Affiliated Hospital of Fujian Medical University

drxun@fjmu.edu.cn+86 13235907575

Outcome results

None listed

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