Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Women only

Assessing PSMA in Patients with Progressive Triple-Negative Breast Cancer

Official 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.

Run by Jules Bordet Institute · NCT06059469 · Data updated 2026-11-12

This study is testing if a special imaging technique can help find a targeted treatment for patients with advanced triple-negative breast cancer.

More TNBC - Triple-Negative Breast Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment20 (estimated)
SponsorJules Bordet Institute
Academic / other
Locations1 site (Brussels)
StatusRecruiting
StartedMay 30, 2022
Main results expectedJune 2, 2025
Study endsDecember 2025
Registry record updatedJuly 18, 2025
Trial IDNCT06059469 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 18 and older with confirmed progressive metastatic TNBC and measurable disease on recent imaging.

Probably not a fit

Patients with skin-only metastatic disease or other active neoplastic diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the expression of Prostate-Specific Membrane Antigen (PSMA) in patients with progressive metastatic triple-negative breast cancer (TNBC) using Ga-PSMA PET/CT imaging. The aim is to assess the feasibility of molecular radionuclide therapy with Lutetium-177 in patients who have measurable disease identified on prior imaging. Participants will undergo PSMA PET/CT before starting their next line of treatment to determine the potential for targeted therapy. This is a single-center, prospective study designed to gather data on PSMA expression in TNBC lesions.

Why it matters

Potential benefit: If successful, this study could lead to new targeted treatment options for patients with refractory metastatic TNBC.

How similar studies have gone: While the approach of using PSMA imaging in breast cancer is relatively novel, similar studies in other cancers have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Institut Jules Bordet
    Brussels, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.