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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

68Ga-PSMA

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

University of Michigan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-PSMA

Arm Description

PET/CT imaging with 68Ga-PSMA

Outcomes

Primary Outcome Measures

Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate 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.

Secondary Outcome Measures

Adverse Events of 68Ga-PSMA Administration

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

Full Information

NCT ID

NCT03689582

First Posted

September 27, 2018

Last Updated

December 7, 2021

Sponsor

University of Michigan Rogel Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03689582

Brief Title

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

Official Title

68GA-PSMA Fusion PET/MRI For Image-Guided Prostate Biopsies

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

due to pandemic related constraints

Study Start Date

November 13, 2018 (Actual)

Primary Completion Date

February 27, 2020 (Actual)

Study Completion Date

February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

68Ga-PSMA

Arm Type

Experimental

Arm Description

PET/CT imaging with 68Ga-PSMA

Intervention Type

Drug

Intervention Name(s)

68Ga-PSMA

Other Intervention Name(s)

Gallium-68 PSMA-HBED-CC, Gallium-68 PSMA-11

Intervention Description

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).

Primary Outcome Measure Information:

Title

Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Adverse Events of 68Ga-PSMA Administration

Description

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

Time Frame

24 hours post injection

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morand R Piert, M.D.

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Available as requested. Data will be archived indefinitely for research purposes.

IPD Sharing Access Criteria

Individuals seeking use of these data should contact the study chair.

Citations:

PubMed Identifier

30226456

Citation

Hicks RM, Simko JP, Westphalen AC, Nguyen HG, Greene KL, Zhang L, Carroll PR, Hope TA. Diagnostic Accuracy of 68Ga-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.

Results Reference

background

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

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