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NCT Number: NCT06059469

PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.

This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.

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Key information

Conditions

TNBC - Triple-Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Institut Jules Bordet

Brussels, Belgium

Location status: Recruiting

Location contact

Loubna Taraji Schiltz

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure
  • Women with ≥ 18 years-old
  • Eastern Cooperative Oncology Group Performance Status of 0 to 2
  • Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT.
  • Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation

Exclusion criteria

  • Pregnant or lactating patients
  • Other active neoplastic disease
  • Treatment by another molecule that is the object of investigation within 30 days
  • Skin only metastatic disease
  • Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study

Treatment and study plan

Ga-PSMA PET/CT

Diagnostic Test

Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment

Primary outcomes

  1. Assess PSMA expression in progressive metastatic TNBC patients

    Time frame: once at baseline prior to the start of the new anti cancer treatment

    uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.

Secondary outcomes

  1. Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).

    Time frame: once at baseline prior to the start of the new anti cancer treatment

    Matching between FDG and PSMA-labelled radiotracers uptake: on PSMA PET/CT and 18F-FDG PET/CT images, each lesion will be identified and faced with the other images. Each imaging pair will be classified as complete match, partial match or no match between the different types of imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Géraldine Gebhart, MD

CONTACT

[email protected]

025413095

Loubna Taraji, Ms

CONTACT

[email protected]

025413781

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

PRISMA: A Single-centre, Prospective Phase II Imaging Study Using PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.

Acronym: PRISMA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2023
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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