Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient

Launched by PRIMO BIOTECHNOLOGY CO., LTD · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called 18F-PSMA-1007 PET/CT, which is designed to help doctors better detect prostate cancer in patients who might have it. Current methods for diagnosing early prostate cancer are not very effective, so researchers hope that this new test can provide clearer images and more accurate information about the disease. The trial will involve male adults over 20 years old who have symptoms that suggest prostate cancer, such as a specific blood test result or abnormal findings during a physical exam.

To participate, men must agree to undergo a prostate biopsy for the first time, and they should not have been previously diagnosed with prostate cancer or received any treatment for it. Participants can expect to undergo non-invasive PET/CT scans, which will help assess the effectiveness of this new diagnostic tool. It’s important to know that certain health conditions could prevent someone from joining, such as serious kidney issues or recent heart problems. This study is taking place across multiple centers in Taiwan, and it aims to provide valuable insights into diagnosing prostate cancer more accurately.

Gender

MALE

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.