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

NCT ID: NCT05048537

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-26
• Study Completion Date: 2023-11-12

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.

Conditions

Biochemical Relapse Fo Malignant Neoplasm of Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

18F-FACBC PET/CT

Intervention Type: RADIATION

10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins

Interventions

18F-FACBC PET/CT

10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Claustrophobia and unstable vital signs
• Disagreement

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Hsien Chou, MD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yi-Hsien Chou, MD

Role: CONTACT

Y06922@ms1.ylh.gov.tw

+886-97252572

Facility Contacts

Yi-Hsien Chou, MD

Role: primary

Y06922@ms1.ylh.gov.tw

097252572

Other Identifiers

202010009MIND

Identifier Type: -

Identifier Source: org_study_id