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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Ga-68 PSMA-11 PET/CT imaging

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate and positive predictive value of Ga-68 PSMA-11 PET/CT images of digital PET/CT and analogue PET/CT	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate and positive predictive value of Ga-68 PSMA-11 digital and analog PET/CT according to PSA level groups	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	12 months
Comparison of SUVs of Ga-68 PSMA-11 digital and analog PET/CT	Comparison of standardized uptake values (SUVs) of Ga-68 PSMA-11 digital and analog PET/CT	12 months

Collaborators and Investigators

• Sponsor: Jin-Sook Ryu
• Investigators: Principal Investigator: Jin-Sook Ryu, MD.PhD., Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Prostate Cancer; Biochemical Recurrence; Ga-68 PSMA-11 PET/CT
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: AMC 2021-0195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No