Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

UNKNOWN

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

Lead Sponsor:

Primo Biotechnology Co., Ltd

Collaborating Sponsors:

ABX advanced biochemical compounds GmbH

Conditions:

Prostate Cancer

Prostate Neoplasm

Eligibility:

MALE

20-100 years

Brief 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 radiopharm...

Eligibility Criteria

Inclusion

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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2024

    Estimated Enrollment :

    230 Patients enrolled

    Trial Details

    Trial ID

    NCT05422105

    Start Date

    July 1 2023

    End Date

    December 31 2024

    Last Update

    August 7 2023

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Tungs'Taichung Metro Harbor Hospital

    Taichung, Taiwan, 43503

    2

    Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, Taiwan, 111