18F-FACBC PET/CT and the PSA Kinetics for PCa Patients With Biochemical Recurrence.

September 20, 2022 updated by: National Taiwan University Hospital

The Correlation Between the Detection Rate of 18F-FACBC PET/CT and the PSA Kinetics for Prostate Cancer Patients With Biochemical Recurrence.

Prostate cancer (PCa) is the fifth-most common cancer for male with a seventh highest cancer-related death in Taiwan. Currently, the incidence and mortality rate are still increasing rapidly. The treatment decision planning is made up by clinical charts like Gleason score (GS), TNM stage and serum prostate-specific antigen (PSA) level. However, after definitive therapy for PCa with either external beam radiotherapy (EBRT) or radical prostatectomy (RP), up to half patients experience biochemical recurrence (BCR). Although not all patients with BCR proceed to develop disease progression, it is important to identify early lesion to initiate salvage treatment.

Anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (18F-FACBC) positron emission tomography (PET) is a imaging marker for L-amino acid transport evaluation. Many cancers including PCa have up-regulated amino acid transport tied to their proliferative potential. Recently, 18F-FACBC was included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of recurrent PCa patients. As we know, PSA level and PSA kinetics are valuable for the prediction of recurrence. The objective of this study is to investigate the correlation between the detection rate of 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • PCa patients with BCR
  • Serum PSA data and pathologic report
  • Agreement consent

Exclusion criteria:

  • Claustrophobia and unstable vital signs
  • Disagreement

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR.
Radiation: 18F-FACBC PET/CT
10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection rate of 18F-FACBC PET/CT
Time Frame: 30 minutes
The correlation between the positive/negative results of 18F-FACBC scans and the PSA kinetics in prostate cancer patients with biochemical recurrence.
30 minutes

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Yi-Hsien Chou, MD, National Taiwan University Hospital

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)

March 26, 2021

Primary Completion (Anticipated)

November 12, 2023

Study Completion (Anticipated)

November 12, 2023

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202010009MIND

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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