Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient (NCT05422105) | Clinical Trial Compass
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Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient
Taiwan230 participantsStarted 2023-07-01
Plain-language summary
The diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive physiological information and then can raise the diagnostic performance. Prostate-specific membrane antigen (PSMA)-targeting pharmaceuticals have been regarded as the most promising diagnostic tool to diagnose patients with prostate cancer. Currently, the 18F-PSMA-1007 as PSMA-targeting 18F-radiolabeled pharmaceuticals have developed and successfully used in patients with intermittent- and high-risk prostate cancer or recurrent prostate cancer. The study aims to understand the diagnostic performance of 18F-PSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of 18F-PSMA-1007 in Taiwan.
Who can participate
Age range20 Years – 100 Years
SexMALE
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Inclusion criteria
✓. The participants are male adults over 20 years old.
✓. 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.
✓. The participants agree to receive TRUS Bx or mpMRI fusion Bx examination.
✓. The participants are the first time to receive a prostatic biopsy.
Exclusion criteria
✕. The participants are diagnosed with prostate cancer before this study.
✕. The participants have received any related treatment for prostate cancer.
✕. The participants have chronic prostatitis.
✕. The participants' serum hemoglobin lowers than 10 mg/dl within 1 month.
✕. The participants' serum platelet lowers than 15 103/uL within 1 month.
. The participants' serum prothrombin time (PT) is prolonged longer than 1.2-fold within 1 month.
✕. The participants' serum active partial prothrombin time (aPPT) is prolonged longer than 45 seconds within 1 month.
✕. The participants have hemorrhagic disease such as Hemophilia, Von Willebrand disease, thrombocytopenia, systemic Lupus Erythematosus, etc. within 6 months.