Clinical Use of 68Ga PSMA-11 PET/CT in Diagnosing, Staging and Restaging Prostate Cancer


Study First Submitted Date 2021-07-27
Study First Posted Date 2021-08-12
Last Update Posted Date 2023-05-19
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-19

Detailed Descriptions

Sequence: 20814716
Description 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care of computed tomography (CT), magnetic resonance imaging (MRI), and bone scintigraphy usually used in staging and restaging prostate cancer. Furthermore, 68Ga PSMA-11 PET/CT offers a higher detection rate of primary and metastatic prostate cancer compared to other available radiotracers used for prostate cancer. It additionally offers enhanced imaging characteristics of greater sensitivity at lower prostate specific antigen (PSA) values and higher target to background ratios than currently available radiotracers. For these reasons, we feel that expanded access to 68Ga PSMA-11 offers better patient care at comparable cost to standard imaging. The population to be treated consists of men in whom metastatic or recurrent prostate cancer is suspected. Patients will be recruited primarily from the clinical practices of the University of Texas Southwestern Medical Center (UTSW) and Parkland Health and Hospital System. Additional patients may be referred for recruitment from physicians outside UTSW. Each patient will receive an IV injection of 68Ga PSMA-11 as a bolus intravenous injection. Depending on patient medical history and Radiology physician preference, the patient may also be injected with 20 milligrams (mg) of furosemide to encourage urination, and the patient will void immediately prior to getting on the scan table. Patients will be scanned on a PET/CT scanner. The patient will be positioned with arms elevated above the head.


Sequence: 200882490
Status Available
Name UT Southwestern Medical Center
City Dallas
State Texas
Zip 75390
Country United States

Facility Contacts

Sequence: 28240951
Facility Id 200882490
Contact Type primary
Name Kelli Key, PhD
Phone 214-648-8152

Facility Investigators

Sequence: 18415996
Facility Id 200882490
Role Principal Investigator
Name Neil Rofsky, MD, MHA

Browse Interventions

Sequence: 96417759 Sequence: 96417760 Sequence: 96417761
Mesh Term Gallium 68 PSMA-11 Mesh Term Radiopharmaceuticals Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term gallium 68 psma-11 Downcase Mesh Term radiopharmaceuticals Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 52408549 Sequence: 52408550 Sequence: 52408551
Name Prostate Cancer Name Prostate Cancer Metastatic Name Prostate Cancer Recurrent
Downcase Name prostate cancer Downcase Name prostate cancer metastatic Downcase Name prostate cancer recurrent

Id Information

Sequence: 40326423
Id Source org_study_id
Id Value STU-2021-0291


Sequence: 42749496
Name United States
Removed False


Sequence: 52716663 Sequence: 52716664
Intervention Type Drug Intervention Type Procedure
Name 68Ga-PSMA-11 Name Positron Emission Tomography/Computed Tomography
Description Injection of 68Ga PSMA-11 Description PET/CT scan after 68Ga PSMA-11 injection


Sequence: 80189384 Sequence: 80189385 Sequence: 80189386
Name Gallium-68 Name PSMA-11 Name PET/CT
Downcase Name gallium-68 Downcase Name psma-11 Downcase Name pet/ct

Browse Conditions

Sequence: 194387863 Sequence: 194387864 Sequence: 194387865 Sequence: 194387866 Sequence: 194387867 Sequence: 194387868 Sequence: 194387869 Sequence: 194387870 Sequence: 194387871 Sequence: 194387872
Mesh Term Prostatic Neoplasms Mesh Term Genital Neoplasms, Male Mesh Term Urogenital Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Genital Diseases, Male Mesh Term Genital Diseases Mesh Term Urogenital Diseases Mesh Term Prostatic Diseases Mesh Term Male Urogenital Diseases
Downcase Mesh Term prostatic neoplasms Downcase Mesh Term genital neoplasms, male Downcase Mesh Term urogenital neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term genital diseases, male Downcase Mesh Term genital diseases Downcase Mesh Term urogenital diseases Downcase Mesh Term prostatic diseases Downcase Mesh Term male urogenital diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48540127
Agency Class OTHER
Lead Or Collaborator lead
Name Dana Mathews

Overall Officials

Sequence: 29408542
Role Principal Investigator
Name Orhan K Oz, MD, PhD
Affiliation UT Southwestern Medical Center

Central Contacts

Sequence: 12071439
Contact Type primary
Name Kelli Key, PhD
Phone 214-648-8152
Role Contact


Sequence: 30902012
Gender Male
Minimum Age 18 Years
Maximum Age N/A
Criteria Inclusion Criteria: One of the following: Patients with suspected recurrence based on elevated serum prostate specific antigen (PSA) level. Patients with suspected metastasis who are candidates for initial definitive therapy. Patients must be able to lie still for approximately 20 – 40 minutes for the PET/CT scans. Patients must be deemed medically stable by their treating physician. Patients must have the ability and willingness to sign a written informed consent. Exclusion Criteria: Patients must not weigh more than the maximum weight limit for the PET/CT scanner table (> 225 kilograms or 500 pounds). Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Patients must not be claustrophobic.
Gender Based True
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254155895
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years

Intervention Other Names

Sequence: 26787134
Intervention Id 52716664

Responsible Parties

Sequence: 29014371
Responsible Party Type Sponsor-Investigator
Name Dana Mathews
Title Professor
Affiliation University of Texas Southwestern Medical Center