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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Drug: 68Ga-PSMA
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 68Ga-PSMA
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title 68Ga-PSMA
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
71
(53 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy
Hide Description 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.
Time Frame Up to ~4 weeks (after planned, standard-of-care biopsy).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Histology Result of Biopsy: Prostate Cancer Benign Histology Result
Hide Arm/Group Description:
Participants whose histology result of biopsy is prostate cancer.
Participants whose histology result of biopsy is benign.
Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: participants
PSMA scan true positive and MRI scan true positive 7 0
PSMA scan true positive and MRI scan false negative 2 0
PSMA scan false negative and MRI scan false negative 1 0
PSMA scan true negative and MRI scan true negative 0 1
2.Secondary Outcome
Title Adverse Events of 68Ga-PSMA Administration
Hide Description Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0.
Time Frame 24 hours post injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Ga-PSMA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: adverse events
0
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 68Ga-PSMA
Hide Arm/Group Description 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).
All-Cause Mortality
68Ga-PSMA
Affected / at Risk (%)
Total   0/11 (0.00%)    
Hide Serious Adverse Events
68Ga-PSMA
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
68Ga-PSMA
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
General disorders   
Claustrophobia   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Early termination leading to small numbers of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Morand Piert, MD
Organization: University of Michigan Rogel Cancer Center
Phone: 734-936-5388
EMail: mpiert@med.umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03689582    
Other Study ID Numbers: UMCC 2018.072
HUM00146602 ( Other Identifier: University of Michigan )
First Submitted: September 27, 2018
First Posted: September 28, 2018
Results First Submitted: October 14, 2021
Results First Posted: January 5, 2022
Last Update Posted: January 5, 2022