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The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer, Prostate Cancer Metastatic

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

68Ga PSMA-11 injection

Positron Emission Tomography/Computed Tomography

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring PET/CT, prostate cancer, Gallium-68, PSMA-11

Eligibility Criteria

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

Inclusion Criteria:

Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
Patients must be scheduled for biopsy or radical prostatectomy
Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
Patients must be medically stable as judged by the patient's physician
Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
Patients who have had a prior biopsy for prostate cancer cannot participate in the study
Patients who have been treated for cancers other than skin cancers
Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies

Sites / Locations

UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with suspected prostate cancer

Arm Description

Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy

Outcomes

Primary Outcome Measures

Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging

Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.

Number of Primary Prostate Lesions Detected by mpMRI

Number of primary prostate lesions will be detected by using mpMRI.

Secondary Outcome Measures

Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT

Number of sites of metastatic prostate lesions will be detected using 68Ga-PSMA-11 PET/CT. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.

Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)

Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).

Full Information

NCT ID

NCT04179968

First Posted

November 25, 2019

Last Updated

March 16, 2023

Sponsor

Dana Mathews

1. Study Identification

Unique Protocol Identification Number

NCT04179968

Brief Title

The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

Official Title

The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 27, 2020 (Actual)

Primary Completion Date

September 9, 2021 (Actual)

Study Completion Date

July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dana Mathews

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).

Detailed Description

This study is designed to evaluate the added value of 68Ga PSMA-11 PET/CT for detection of additional primary prostate cancer lesions compared to multiparametric magnetic resonance imaging (mpMRI) in a group of patients with elevated PI-RADS scores and PSA. We propose that the addition of early dynamic 68Ga PSMA-11 PET/CT imaging to the more usual delayed imaging will enhance detection of primary lesions and additional lesions not detected on the mpMRI. In addition, the dynamic imaging will allow us to evaluate the kinetics of uptake in the prostate gland. It is possible that even in the absence of focal uptake, hyperemia of the gland could indicate the presence of an occult primary. A second purpose of this research is to examine the value of 68Ga PSMA-11 PET/CT in this same group of patients in detecting metastatic disease at initial staging in comparison with current standard of care imaging such as computed tomography (CT) and magnetic resonance imaging (MRI).

6. Conditions and Keywords

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

Prostate Cancer, Prostate Cancer Metastatic

Keywords

PET/CT, prostate cancer, Gallium-68, PSMA-11

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Unblinded, single arm imaging study

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with suspected prostate cancer

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

68Ga PSMA-11 injection

Intervention Description

Injection of 68Ga PSMA-11

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography/Computed Tomography

Other Intervention Name(s)

PET/CT

Intervention Description

PET/CT scan after 68Ga PSMA-11 injection

Primary Outcome Measure Information:

Title

Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging

Description

Time Frame

During PET/CT imaging, up to 2 hours

Title

Number of Primary Prostate Lesions Detected by mpMRI

Description

Number of primary prostate lesions will be detected by using mpMRI.

Time Frame

During mpMRI, up to 2 hours

Secondary Outcome Measure Information:

Title

Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT

Description

Time Frame

During PET/CT imaging, up to 2 hours

Title

Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)

Description

Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).

Time Frame

During CT/MRI imaging, up to 2 hours

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4 In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level. Patients must be scheduled for biopsy or radical prostatectomy Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study Patients must be medically stable as judged by the patient's physician Patients must be able to lie still for a total of 60 minutes for the PET/CT scans Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study Patients who have had a prior biopsy for prostate cancer cannot participate in the study Patients who have been treated for cancers other than skin cancers Subjects may not be receiving any other investigational agents for the treatment of the cancer under study Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds) History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orhan K Oz, MD, PhD

Organizational Affiliation

UT Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

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