Using 18F-PSMA-1007 PET/CT to Diagnose Prostate Cancer

Multicenter Evaluation of Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Patients With Suspected Prostate Cancer

This study is testing a new type of imaging called 18F-PSMA-1007 PET/CT to see if it can help find prostate cancer in men who might have it.

Quick facts

• Study type: Observational
• Enrollment: 230 (estimated)
• Ages: 20 Years to 100 Years
• Sex: Male
• Sponsor: Primo Biotechnology Co., Ltd (industry)
• Locations: 2 sites (Taichung and 1 other locations)
• Trial ID: NCT05422105 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the diagnostic performance of 18F-PSMA-1007 PET/CT imaging in patients suspected of having prostate cancer. It aims to provide a non-invasive method for detecting prostate cancer by utilizing a radiopharmaceutical that targets prostate-specific membrane antigen (PSMA). The study will involve male adults over 20 years old who have elevated PSA levels or abnormal findings from a digital rectal exam (DRE). Participants will undergo imaging and biopsy procedures to assess the effectiveness of this diagnostic tool across different stages of prostate cancer.

Who should consider this trial

Good fit: Ideal candidates are male adults over 20 years old with suspected prostate cancer indicated by specific PSA levels or abnormal DRE findings.

Not a fit: Patients who have already been diagnosed with prostate cancer or have received prior treatment for the condition will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the accuracy of prostate cancer diagnosis, leading to better patient outcomes.

How similar studies have performed: Other studies have shown promising results with PSMA-targeting imaging techniques, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria

1. The participants are male adults over 20 years old.
2. The participants are suspected prostate cancer patients by a serum PSA value of 4-20 ng/ml or a serum PSA value of \< 4ng/ml but noted abnormal lesion by DRE.
3. The participants agree to receive TRUS Bx or mpMRI fusion Bx examination.
4. The participants are the first time to receive a prostatic biopsy.

Exclusion Criteria

1. The participants are diagnosed with prostate cancer before this study.
2. The participants have received any related treatment for prostate cancer.
3. The participants have chronic prostatitis.
4. The participants' serum hemoglobin lowers than 10 mg/dl within 1 month.
5. The participants' serum platelet lowers than 15 103/uL within 1 month.
6. The participants' serum prothrombin time (PT) is prolonged longer than 1.2-fold within 1 month.
7. The participants' serum active partial prothrombin time (aPPT) is prolonged longer than 45 seconds within 1 month.
8. The participants have hemorrhagic disease such as Hemophilia, Von Willebrand disease, thrombocytopenia, systemic Lupus Erythematosus, etc. within 6 months.
9. The participants have conditions of poor immunity status such as HIV infection, receiving treatment for other cancer, DM poor control, use of immunomodulator (ex.

   steroid, etc.) within 6 months.
10. The participants have hypertension poor control that is BP cannot be controlled lower than 140/90mmHg whether or not taking medication within 6 months.
11. The participants have suffered from CVA including infarctions and hemorrhages within 6 months.
12. The participants have suffered from angina including stable and unstable types within 6 months.
13. The participants have suffered from arrythmia poor control within 6 months.
14. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months.
15. The participants are allergic to any radiopharmaceutical or imaging agent.
16. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months
17. The participants suffered acute kidney injury within 6 months.
18. The participants are absolute and relative contraindications to MRI examination.

Where this trial is running

Taichung and 1 other locations

• Tungs'Taichung Metro Harbor Hospital — Taichung, Taiwan (RECRUITING)
• Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Yating Huang

Conditions: Prostate Cancer, Prostate Neoplasm, Prostate cancer, [18F]FPSMA-1007, mpMRI