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

NCT04179968 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STU-2019-1198
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Prostate Cancer Metastatic

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  During PET/CT imaging, up to 2 hours

• Number of Primary Prostate Lesions Detected by mpMRI

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

  During mpMRI, up to 2 hours

Secondary Outcomes (2)

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

  During PET/CT imaging, up to 2 hours

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

  During CT/MRI imaging, up to 2 hours

Study Arms (1)

Patients with suspected prostate cancer

EXPERIMENTAL

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; Procedure: Positron Emission Tomography/Computed Tomography

Interventions

68Ga PSMA-11 injection DRUG

Injection of 68Ga PSMA-11

Patients with suspected prostate cancer

Positron Emission Tomography/Computed Tomography PROCEDURE

PET/CT scan after 68Ga PSMA-11 injection

Also known as: PET/CT

Patients with suspected prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana Mathews: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Parrott D, Yuan Q, Pinho D, Xi Y, Costa DN, De Leon AD, Dakanali M, Sun X, Oz OK, Bowen S, Rofsky NM, Mathews D, Pedrosa I. Characterization of suspicious prostate lesions at multiparametric MRI with dynamic 68 Ga-Gozetotide PET/CT. EJNMMI Rep. 2025 Oct 13;9(1):35. doi: 10.1186/s41824-025-00268-2.

  PMID: 41077599 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Kelli Key, Ph.D.
• Organization: UT Southwestern Medical Center

Kelli.Key@UTSouthwestern.edu

214-648-8152

Study Officials

• Orhan K Oz, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Unblinded, single arm imaging study

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: January 27, 2020
• Primary Completion: September 9, 2021
• Study Completion: July 15, 2022
• Last Updated: March 20, 2023
• Results First Posted: December 20, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)