PSMA PET Combined With MRI for the Detection of PCa

Part of paid clinical trials in Los Angeles, California.

Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited
Study ID
NCT07052214
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Carcinoma of the Prostate
  • Diagnostic Imaging
  • Elevated PSA
  • PCA
  • PSMA PET
  • Positron Emission Tomography
  • Prostate Biopsy
  • Prostate Cancer
  • Prostatic Neoplasm

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 68Ga-PSMA-11 — DRUG
    The radioconjugate 68Ga-PSMA-11 is composed of a human PSMA-targeting ligand peptide conjugated via the acyclic radiometal chelator, N, N'-bis \[2-hydroxy-5-(carboxyethyl)benzyl\] ethylenediamine-N, N'-diacetic acid (HBED-CC) to the radioisotope Gallium68 ( 68Ga); which binds to PSMA on the surface of cells expressing PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. 68Ga is a β+ (beta) ray emitting radionuclide that allows precise imaging via PET.

Study Details

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).

Key Dates

First listed
Jul 4, 2025
Start date
Aug 18, 2025
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
338 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Illuccix: 68Ga-PSMA-11/Gallium Ga 68 Gozetotide
    This is a single arm study. All participants will first undergo mpMRI and PSMA PET scans (one single IV bolus of Gallium Ga 68 Gozetotide administered)

Primary Outcome Measure

Primary Objective [ Time Frame: 12 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095
Ankush Sachdeva
[email protected]
310-794-3452
University of California San FranciscoSan FranciscoCalifornia94158
An Nguyen
[email protected]
510-545-9040
Impression ImagingBoca RatonFlorida33433
Jessica Myers
[email protected]
352-525-5760
University of MiamiMiamiFlorida33136
Elena Cortizas
[email protected]
305-243-3593
UroPartners,LLCChicagoIllinois60657
Kelly Liberatore
[email protected]
610-667-0458
Indiana UniversityIndianapolisIndiana46202
Ashley Frazee
[email protected]
317-278-4959
Southern UrologyLafayetteLouisiana70508
Simone Olivier
[email protected]
337-422-3770
Ochsner Clinic FoundationNew OrleansLouisiana70121
Rachel Graham
[email protected]
504-842-2961
Washington UniversitySt LouisMissouri63110
Megan Luther
[email protected]
314-747-2012
Weill CornellNew YorkNew York10065
Alexis Watson
[email protected]
646-962-2347
MidLantic UrologyPhiladelphiaPennsylvania19004
Kelly Liberatore
[email protected]
610-667-0458
Atlantic Urology SpecialistsMyrtle BeachSouth Carolina29572
Crystal Mitchell
[email protected]
843-449-1010
The Conrad Pearson ClinicGermantownTennessee38138
Russell Gribsby
[email protected]
901-236-0957
Urology Associates of NashvilleNashvilleTennessee37209
Rick Trotter
[email protected]
615-250-9268
Urology AustinAustinTexas78759
Christine Chau
[email protected]
512-410-3773
Urology of VirginiaVirginia BeachVirginia23462
Julia Csenar
[email protected]
(757) 452-3463

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