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

Primary Purpose

Biochemical Relapse Fo Malignant Neoplasm of Prostate

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
18F-FACBC PET/CT
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Biochemical Relapse Fo Malignant Neoplasm of Prostate focused on measuring Prostate cancer, 18F-FACBC, Biochemical recurrence

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

  • Claustrophobia and unstable vital signs
  • Disagreement

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR.

Arm Description

Outcomes

Primary Outcome Measures

The detection rate of 18F-FACBC PET/CT
The correlation between the positive/negative results of 18F-FACBC scans and the PSA kinetics in prostate cancer patients with biochemical recurrence.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2021
Last Updated
September 20, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05048537
Brief Title
18F-FACBC PET/CT and the PSA Kinetics for PCa Patients With Biochemical Recurrence.
Official Title
The Correlation Between the Detection Rate of 18F-FACBC PET/CT and the PSA Kinetics for Prostate Cancer Patients With Biochemical Recurrence.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
November 12, 2023 (Anticipated)
Study Completion Date
November 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biochemical Relapse Fo Malignant Neoplasm of Prostate
Keywords
Prostate cancer, 18F-FACBC, Biochemical recurrence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR.
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
18F-FACBC PET/CT
Intervention Description
10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins
Primary Outcome Measure Information:
Title
The detection rate of 18F-FACBC PET/CT
Description
The correlation between the positive/negative results of 18F-FACBC scans and the PSA kinetics in prostate cancer patients with biochemical recurrence.
Time Frame
30 minutes

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
prostate cancer patients with biochemical recurrence
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: PCa patients with BCR Serum PSA data and pathologic report Agreement consent Exclusion criteria: Claustrophobia and unstable vital signs Disagreement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Hsien Chou, MD
Phone
+886-97252572
Email
Y06922@ms1.ylh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Hsien Chou, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Hsien Chou, MD
Phone
097252572
Email
Y06922@ms1.ylh.gov.tw

12. IPD Sharing Statement

Learn more about this trial

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

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