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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

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ClinicalTrials.gov Identifier: NCT04846894
Recruitment Status : Active, not recruiting
First Posted : April 15, 2021
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Jin-Sook Ryu, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: Ga-68 PSMA-11 PET/CT imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Biochemical Recurrence
Prostate cancer patient with biochemical recurrence
Diagnostic Test: Ga-68 PSMA-11 PET/CT imaging
Sequential PET/CT imaging using analog and digital PET/CT scanners after single intravenous injection of Ga-68 PSMA-11




Primary Outcome Measures :
  1. Detection rate and positive predictive value of Ga-68 PSMA-11 PET/CT images of digital PET/CT and analogue PET/CT [ Time Frame: 12 months ]
    Comparison of detection rate and positive predictive value of Ga-68 PSMA-11 PET/CT images of digital PET/CT and analogue PET/CT in biochemical recurrence (BCR) patients


Secondary Outcome Measures :
  1. Detection rate and positive predictive value of Ga-68 PSMA-11 digital and analog PET/CT according to PSA level groups [ Time Frame: 12 months ]
    Comparison of detection rate and positive predictive value of Ga-68 PSMA-11 digital and analog PET/CT according to PSA level groups in BCR patients

  2. Comparison of SUVs of Ga-68 PSMA-11 digital and analog PET/CT [ Time Frame: 12 months ]
    Comparison of standardized uptake values (SUVs) of Ga-68 PSMA-11 digital and analog PET/CT



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846894


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 05505
Sponsors and Collaborators
Jin-Sook Ryu
Investigators
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Principal Investigator: Jin-Sook Ryu, MD.PhD. Asan Medical Center
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Responsible Party: Jin-Sook Ryu, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04846894    
Other Study ID Numbers: AMC 2021-0195
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Sook Ryu, Asan Medical Center:
Prostate Cancer
Biochemical Recurrence
Ga-68 PSMA-11 PET/CT
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Disease Attributes
Pathologic Processes