Trial Outcomes & Findings for Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer (NCT NCT03689582)

Last Updated: 2022-01-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Up to ~4 weeks (after planned, standard-of-care biopsy).

Results posted on

2022-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	68Ga-PSMA 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 Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	68Ga-PSMA n=11 Participants 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).
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to ~4 weeks (after planned, standard-of-care biopsy).

Outcome measures

Outcome measures
Measure	Histology Result of Biopsy: Prostate Cancer n=11 Participants Participants whose histology result of biopsy is prostate cancer.	Benign Histology Result n=11 Participants Participants whose histology result of biopsy is benign.
Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy PSMA scan true positive and MRI scan true positive	7 participants	0 participants
Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy PSMA scan true positive and MRI scan false negative	2 participants	0 participants
Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy PSMA scan false negative and MRI scan false negative	1 participants	0 participants
Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy PSMA scan true negative and MRI scan true negative	0 participants	1 participants

SECONDARY outcome

Timeframe: 24 hours post injection

Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0.

Outcome measures

Outcome measures
Measure	Histology Result of Biopsy: Prostate Cancer n=11 Participants Participants whose histology result of biopsy is prostate cancer.	Benign Histology Result Participants whose histology result of biopsy is benign.
Adverse Events of 68Ga-PSMA Administration	0 adverse events	—

Adverse Events

68Ga-PSMA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	68Ga-PSMA n=11 participants at risk 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).
General disorders Claustrophobia	9.1% 1/11 • Number of events 1 • 24 hours

Additional Information

Morand Piert, MD

University of Michigan Rogel Cancer Center

Phone: 734-936-5388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place