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Ga-68 PSMA-11 PET/CT in Patients With Biochemical Recurrence of Prostate Cancer: Digital PET/CT Versus Analog PET/CT | Clinical Trials | Clareo Health

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Ga-68 PSMA-11 PET/CT in Patients With Biochemical Recurrence of Prostate Cancer: Digital PET/CT Versus Analog PET/CT

Diagnostic Performance of Ga-68 PSMA-11 PET/CT in Patients With Biochemical Recurrence After Prostatectomy: A Comparison of Digital PET/CT and Analog PET/CT Scanner Images

NCT04846894•Jin-Sook Ryu

View on ClinicalTrials.gov

Summary

Ga-68 PSMA-11 PET/CT is known as useful method for localizing recurred tumor lesions in prostate cancer patients with biochemical recurrence \[elevated serum prostate specific antigen (PSA) after radical prostatectomy\]. The recent digital PET/CT which is known to show better resolution and sensitivity than analogue PET/CT may have better performance for detecting early small recurred tumor lesions. This study is intended to compare the diagnostic performance (detection rate and positive predictive value) of Ga-68 PSMA-11 PET/CT using analogue PET/CT scanner and digital PET/CT scanner in same patients who had biochemical recurrence of prostate cancer.

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Preliminary study - Establishment of Ga-68 PSMA-11 PET/CT imaging conditions (three subjects)
•* Equal or more than 19 years old
•* Biopsy proven prostate cancer patients with high risk group (serum PSA\> 20 ng/ml) or metastatic prostate cancer patients identified on other imaging modalities prior to Ga-68 PSMA-11 PET/CT imaging
•2. Main study (40 subjects)
•* Equal or more than 19 years old
•* Patients who had previously undergone radical prostatectomy and were histologically diagnosed with prostate cancer.
•* Patients identified with biochemical recurrence through serum PSA tests during postoperative follow-up (Serum PSA level equal or more than 0.2 ng/ml at least two times and one of the tests was conducted within one month before consent to the study) in which metastatic lesions were not found or uncertain in standard imaging modalities (abdominal/Pelvic CT, bone scan).
•* Patients who can be followed up clinically, including serum PSA tests, for at least 6 months after consent to the study at this hospital.

Exclusion Criteria

•1. Preliminary study - Establishment of Ga-68 PSMA-11 PET/CT imaging conditions (three subjects)
•* Primary cancer other than prostate cancer has been previously diagnosed or has occurred simultaneously with prostate cancer; Previous primary cancer other than prostate cancer is a local disease and has been cured completely shall be an exception.
•* Subjects who has concurrent severe and/or uncontrolled and/or unstable medical disease (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) based on the judgment of the investigator
•* Subjects who cannot perform PET/CT imaging due to claustrophobia, dyskinesia, anxiety disorders, etc.
•2. Main study (40 subjects)
•* Primary cancer other than prostate cancer has been previously diagnosed or has occurred simultaneously with prostate cancer; Previous primary cancer other than prostate cancer is a local disease and has been cured completely shall be an exception.
•* Subjects who cannot perform CT, bone scan, etc., which are standard diagnostic procedures for lesion localization in case of biochemical recurrence.
•* Subjects who has concurrent severe and/or uncontrolled and/or unstable medical disease (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) based on the judgment of the investigator
•* Subjects who cannot perform PET/CT imaging due to claustrophobia, dyskinesia, anxiety disorders, etc.
•* Subjects who might make the collection of complete data difficult or impossible due to personal circumstances or other reasons, in the judgment of the investigator.

Locations (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Key Dates

Start Date

April 13, 2021

Primary Completion Date

June 1, 2022

Completion Date

June 1, 2023

Last Updated

September 29, 2021

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Ga-68 PSMA-11 PET/CT imaging

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ga-68 PSMA-11 PET/CT in Patients With Biochemical Recurrence of Prostate Cancer: Digital PET/CT Versus Analog PET/CT

Inclusion Criteria

Exclusion Criteria

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