Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient
NCT ID: NCT05422105
Last Updated: 2023-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
230 participants
OBSERVATIONAL
2023-07-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Suspected Prostate Cancer
18F-PSMA-1007
18F-PSMA-1007 PET/CT
Interventions
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18F-PSMA-1007
18F-PSMA-1007 PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
100 Years
MALE
No
Sponsors
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ABX advanced biochemical compounds GmbH
INDUSTRY
Primo Biotechnology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Tungs'Taichung Metro Harbor Hospital
Taichung, , Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PB01-MCTNSPC
Identifier Type: -
Identifier Source: org_study_id
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