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PSMA PET Combined With MRI for the Detection of PCa

NCT07052214 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-09-10

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DRUG

68Ga-PSMA-11

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.

Sponsors & Collaborators

  • Telix Innovations S.A.

    collaborator UNKNOWN

  • Telix Pharmaceuticals (Innovations) Pty Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2026-06-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • Australia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07052214 on ClinicalTrials.gov