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

• ClinicalTrials.gov Identifier: NCT04179968
• Recruitment Status: Completed
• First Posted: November 27, 2019
• Results First Posted: December 20, 2022
• Last Update Posted: March 20, 2023
• Sponsor: Dana Mathews
• Information provided by (Responsible Party): Dana Mathews, University of Texas Southwestern Medical Center

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).

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Prostate Cancer Metastatic	Drug: 68Ga PSMA-11 injection; Procedure: Positron Emission Tomography/Computed Tomography	Phase 2

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Unblinded, single arm imaging study
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
• Actual Study Start Date: January 27, 2020
• Actual Primary Completion Date: September 9, 2021
• Actual Study Completion Date: July 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patients with suspected prostate cancer; 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	Drug: 68Ga PSMA-11 injection; Injection of 68Ga PSMA-11; Procedure: Positron Emission Tomography/Computed Tomography; PET/CT scan after 68Ga PSMA-11 injection; Other Name: PET/CT

Outcome Measures

Primary Outcome Measures :

1. Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging [ Time Frame: During PET/CT imaging, up to 2 hours ]
   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.
2. Number of Primary Prostate Lesions Detected by mpMRI [ Time Frame: During mpMRI, up to 2 hours ]
   Number of primary prostate lesions will be detected by using mpMRI.

Secondary Outcome Measures :

1. Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT [ Time Frame: During PET/CT imaging, up to 2 hours ]
   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.
2. Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI) [ Time Frame: During CT/MRI imaging, up to 2 hours ]
   Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Sponsors and Collaborators

Dana Mathews

Investigators

• Principal Investigator: Orhan K Oz, MD, PhD; UT Southwestern Medical Center

  Study Documents (Full-Text)

Documents provided by Dana Mathews, University of Texas Southwestern Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] March 10, 2021

Informed Consent Form  [PDF] April 6, 2020

More Information

• Responsible Party: Dana Mathews, Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT04179968
• Other Study ID Numbers: STU-2019-1198
• First Posted: November 27, 2019
• Results First Posted: December 20, 2022
• Last Update Posted: March 20, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dana Mathews, University of Texas Southwestern Medical Center:

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

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Gallium 68 PSMA-11; Radiopharmaceuticals; Molecular Mechanisms of Pharmacological Action