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

Study Overview
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Brief Summary
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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.

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

Conditions
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Biochemical Relapse Fo Malignant Neoplasm of Prostate

Intervention / Treatment
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* Radiation: 18F-FACBC PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: PCa patients with BCR Serum PSA data and pathologic report Agreement consent Exclusion criteria: Claustrophobia and unstable vital signs Disagreement

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention 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.<br> | Radiation: 18F-FACBC PET/CT<br>* 10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, 18F-FACBC, Biochemical recurrence