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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422105
• Other study ID #: PB01-MCTNSPC
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Primo Biotechnology Co., Ltd
• Contact: Yating Huang
• Phone: +886916140167
• Email: frankie.huang[@]primobt.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• 18F-PSMA-1007
18F-PSMA-1007 PET/CT

Locations

Country	Name	City	State
Taiwan	Tungs'Taichung Metro Harbor Hospital	Taichung
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Primo Biotechnology Co., Ltd	ABX advanced biochemical compounds GmbH

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Performance	Sensitivity, Specificity, NPV, PPV	7-14 days after PET/CT