Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179968
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Dana Mathews, University of Texas Southwestern Medical Center

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gallium

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




Primary Outcome Measures :
  1. Focus of Uptake in Prostate [ Time Frame: Up to 3 years ]
    Correlation between foci of update detected on PET/CT to detected abnormalities on standard of care mpMRI and pathology specimens.

  2. Focus of Update Outside Prostate [ Time Frame: Up to 3 years ]
    Correlation between foci of update detected on PET/CT to lesions seen on conventional standard of care imaging, including pelvic CT or MRI and bone scintigraphy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • Patients must be scheduled for biopsy or radical prostatectomy
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179968


Contacts
Layout table for location contacts
Contact: Kelli Key, PhD 214-648-8152 Kelli.Key@UTSouthwestern.edu

Locations
Layout table for location information
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kelli Key, PhD    214-648-8152    Kelli.Key@UTSouthwestern.edu   
Principal Investigator: Neil Rofsky, MD, MHA         
Sponsors and Collaborators
Dana Mathews
Investigators
Layout table for investigator information
Principal Investigator: Neil Rofsky, MD, MHA UT Southwestern Medical Center

Layout table for additonal 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    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases