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

Not Applicable

• Conditions: Biochemical Relapse Fo Malignant Neoplasm of Prostate
• Interventions: Radiation: 18F-FACBC PET/CT

• Registration Number: NCT05048537
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-26
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-17
• Status Verified: 2021-11
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-11-12
• Study Completion: 2023-11-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan