Clinical trial · Observational
The Application Value of Prostate Specific Membrane Antigen PET/CT in Biopsy Free of PSA Grey Area Prostate Cancer
Application Value of Biopsy Free Technique for Prostate Specific Antigen Grey Area Prostate Cancer Based on 18F-Prostate Specific Membrane Antigen-1007 Positron Emission Tomography/Computerized Tomography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone. The main questions it aims to answer are: proportion of men who could have avoided biopsy with positive PSMA-PET and no clinically significant cancer detected on biopsy. Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo prostate biopsy Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Non-Prostate Cancer
- description
- Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed non-prostate cancer after biopsies
- label
- Prostate Cancer
- description
- Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed prostate cancer after biopsies
Primary outcomes (2)
- measure
- detection rate of prostate cancer
- timeFrame
- about 1 year
- description
- detection rate of prostate cancer
- measure
- detection rate of clinical significant prostate cancer
- timeFrame
- about 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * PSA (4-10 ng/mL) * MRI and PSMA PET/CT were not contraindicated * Did not receive prostate-related treatment * There are no contraindications to biopsy Exclusion Criteria: * Coexisting with other malignancies
References
Publications (1)
- DERIVEDLuo L, Wang R, Bai L, Shang J, Wang X, Chang R, Dong W, Li Y, Li Y, Liang H, Xie H, Duan X. The accuracy of fluorine 18-labelled prostate-specific membrane antigen PET/CT and MRI for diagnosis of prostate cancer in PSA grey zone. Br J Cancer. 2025 Feb;132(3):253-258. doi: 10.1038/s41416-024-02934-x. Epub 2024 Dec 19. PMID 39702584