NCT04179968

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

Completed Phase 2 Results posted Last updated 20 March 2023

What this trial tests

Phase 2 trial testing 68Ga PSMA-11 injection in Prostate Cancer in 20 participants. Completed in 15 July 2022.

Timeline

27 January 2020

Primary endpoint
9 September 2021

15 July 2022

Quick facts

Lead sponsor	Dana Mathews
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	27 January 2020
Primary completion	9 September 2021
Estimated completion	15 July 2022
Sites	1 location across United States

Drugs / interventions tested

• 68Ga PSMA-11 injection — full drug profile →
• Positron Emission Tomography/Computed Tomography

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Prostate Cancer Metastatic — all drugs for Prostate Cancer Metastatic →

Sponsor

Dana Mathews — full company profile →

Who can join

18 and older, male only, with Prostate Cancer or Prostate Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Patients With Suspected Prostate Cancer	24

Number of Primary Prostate Lesions Detected by mpMRI Primary · During mpMRI, up to 2 hours

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

Group	Value	95% CI
Patients With Suspected Prostate Cancer	37

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

Group	Value	95% CI
Patients With Suspected Prostate Cancer	7

Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI) Secondary · During CT/MRI imaging, up to 2 hours

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

Group	Value	95% CI
Patients With Suspected Prostate Cancer	5

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Suspected Prostate Cancer

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (4 terms — click to expand)

Reaction	System	Patients With Suspected Pr…
Back Pain	Musculoskeletal and connective tissue disorders	—
Fatigue	General disorders	—
Nausea without emesis	Gastrointestinal disorders	—
Maculopapular rash	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04179968 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of [⁶⁸Ga]PSMA PET/CT for Clinical Suspicion of Prostate Cancer in Patients with or without Previous Negative Biopsy: A Systematic Review.
   Caracciolo M, Castello A, Urso L, Borgia F, et al · · 2022 · cited 11× · PMID 36291820 · DOI 10.3390/cancers14205036
2. Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective.
   Ng TSC, Gao X, Salari K, Zlatev DV, et al · · 2021 · cited 4× · PMID 34395293 · DOI 10.3389/fonc.2021.722277
3. Characterization of suspicious prostate lesions at multiparametric MRI with dynamic <sup>68</sup> Ga-Gozetotide PET/CT.
   Parrott D, Yuan Q, Pinho D, Xi Y, et al · · 2025 · PMID 41077599 · DOI 10.1186/s41824-025-00268-2