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Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03689582
Recruitment Status : Terminated (due to pandemic related constraints)
First Posted : September 28, 2018
Results First Posted : January 5, 2022
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE September 28, 2018
Results First Submitted Date  ICMJE October 14, 2021
Results First Posted Date  ICMJE January 5, 2022
Last Update Posted Date January 5, 2022
Actual Study Start Date  ICMJE November 13, 2018
Actual Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2021)
Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy [ Time Frame: Up to ~4 weeks (after planned, standard-of-care biopsy). ]
Fusion PET/MRI is the combination of 68Ga-PSMA Positron Emission Tomography/Computed Tomography (PET/CT) plus Multiparametric MRI (mpMRI)-guided biopsy. Reference standard will be pathology-defined as targeted plus standard prostate biopsy, and prostatectomy, when available. The original intent was to determine the sensitivity and specificity of standard-of-care Multiparametric MRI (mpMRI) alone (using PI-RADS version 2) and fusion PET/MRI for the detection of primary Gleason ≥3+4 cancer, and to estimate the positive likelihood ratio (LR) of each. However, due to pandemic-related early closure of the study, enrollment was less than 15% of the enrolment goal necessary to achieve statistical power. Therefore, it is not possible to responsibly report the originally listed outcome measure of likelihood ratio. Instead, the results table displays the summary of collected imaging data, categorized by type of scan, in comparison to the reference standard histopathology.
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Sensitivity and specificity of multiparametric MRI (mpMRI) in combination with 68Ga-PSMA Positron Emission Tomography/Computed Tomography (PET/CT) (i.e., fusion PET/MRI) for the detection of primary Gleason score ≥ 3+4 prostate cancer. [ Time Frame: Up to ~4 weeks (after planned, standard-of-care biopsy). ]
Reference standard will be pathology-defined as targeted plus standard prostate biopsy, and prostatectomy, when available. Investigators will employ mixed effects logistic regression model to estimate the positive likelihood ratio (LR) of the combination of 68Ga-PSMA-guided plus mpMRI- guided biopsy (fusion PET/MRI) for the detection of primary Gleason ≥ 3+4 cancer compared to mpMRI-guided biopsy (using Prostate Imaging - Reporting and Data System [PI-RADS] version 2) alone.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2021)
Adverse Events of 68Ga-PSMA Administration [ Time Frame: 24 hours post injection ]
Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Adverse events of 68Ga-PSMA administration [ Time Frame: 24 hours post injection ]
Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer
Official Title  ICMJE 68GA-PSMA Fusion PET/MRI For Image-Guided Prostate Biopsies
Brief Summary The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.
Detailed Description

In this study, two different imaging tests are being compared: a) 68Ga-PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) and b) Magnetic Resonance Imaging (MRI) of the prostate gland. Participants already have received the MRI, and the results were either suspicious of or definitive for prostate cancer. Both tests (MRI and 68Ga-PSMA PET/CT) are expected to show tumor tissue when more aggressive, but one test could be more accurate than the other test.

Another important question is whether these imaging tests will perform as good or better than prostate biopsies in finding all prostate cancer lesions in need for treatment. If imaging would be comparable or better than biopsies, then imaging may be able to replace invasive biopsies for some indications in the future.

To investigate these questions, participants are asked to undergo a 68Ga-PSMA PET/CT before a planned prostate biopsy procedure. After the biopsy procedure is performed, investigators will compare the imaging results from 68Ga-PSMA with those from the MRI and determine which test is more accurate.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: 68Ga-PSMA

Positron Emission Tomography/Computed Tomography (PET/CT) imaging with 68Ga-PSMA:

68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).

Other Names:
  • Gallium-68 PSMA-HBED-CC
  • Gallium-68 PSMA-11
Study Arms  ICMJE Experimental: 68Ga-PSMA
PET/CT imaging with 68Ga-PSMA
Intervention: Drug: 68Ga-PSMA
Publications * Hicks RM, Simko JP, Westphalen AC, Nguyen HG, Greene KL, Zhang L, Carroll PR, Hope TA. Diagnostic Accuracy of (68)Ga-PSMA-11 PET/MRI Compared with Multiparametric MRI in the Detection of Prostate Cancer. Radiology. 2018 Dec;289(3):730-737. doi: 10.1148/radiol.2018180788. Epub 2018 Sep 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 19, 2021)
11
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
100
Actual Study Completion Date  ICMJE February 27, 2020
Actual Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
  • Treating physician has already indicated a need for a prostate biopsy procedure.
  • Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

Exclusion Criteria:

  • Prostate biopsy within 12 weeks before enrollment
  • Acute prostatitis within the last 6 months
  • Current non-urologic bacterial infection requiring active treatment with antibiotics
  • Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
  • Body weight greater than 350 lbs (158 Kg)
  • Inability or unwillingness to receive a prostate biopsy procedure
  • Unable to lie flat, still, or tolerate a PET/CT scan
  • Unable to provide own consent
  • Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689582
Other Study ID Numbers  ICMJE UMCC 2018.072
HUM00146602 ( Other Identifier: University of Michigan )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Available as requested. Data will be archived indefinitely for research purposes.
Access Criteria: Individuals seeking use of these data should contact the study chair.
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Morand R Piert, M.D. University of Michigan
PRS Account University of Michigan Rogel Cancer Center
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP