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

August 3, 2023 updated by: Primo Biotechnology Co., Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 43503
        • Recruiting
        • Tungs'Taichung Metro Harbor Hospital
        • Principal Investigator:
          • Yen-Chuan Ou
        • Contact:
      • Taipei, Taiwan, 111
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Yen-Kung Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients with suspected prostate cancer had a serum PSA value between 4 and 20 ng/ml or a serum PSA value of < 4ng/ml but noted abnormal lesions by digital rectal examination.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suspected Prostate Cancer
Drug: 18F-PSMA-1007
18F-PSMA-1007 PET/CT
Other Names:
  • [18F]FPSMA-1007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance
Time Frame: 7-14 days after PET/CT
Sensitivity, Specificity, NPV, PPV
7-14 days after PET/CT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Primo Biotechnology Co., Ltd

Collaborators

ABX advanced biochemical compounds GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB01-MCTNSPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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