Clinical trial Recruiting at 1 site Observational Men only

Lutetium-177 dosimetry to predict response to PSMA radioligand therapy in metastatic prostate cancer

Official title: LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.

Run by Jules Bordet Institute · NCT07370597 · Data updated 2026-11-12

This project will test whether measuring the radiation dose delivered (dosimetry) from Lutetium-177 PSMA therapy can predict which men with metastatic prostate cancer will respond.

More Prostate Cancer (Adenocarcinoma) trials

Quick facts

Study typeObservational
SexMen only
Enrollment110 (estimated)
SponsorJules Bordet Institute
Academic / other
Locations1 site (Brussels)
StatusRecruiting
StartedFebruary 1, 2026
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedJanuary 27, 2026
Trial IDNCT07370597 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18 or older with progressive metastatic prostate adenocarcinoma who are candidates for 177Lu-PSMA radioligand therapy and have at least one PSMA-avid lesion (uptake above liver) are ideal candidates.

Probably not a fit

Patients without PSMA-avid disease, those who are not eligible for 177Lu-PSMA therapy, or those who cannot attend the Brussels treatment center are unlikely to benefit from participation.

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

What this trial studies

This is an observational, single-center study enrolling men with progressive metastatic prostate adenocarcinoma who are scheduled to receive 177Lu-PSMA radioligand therapy. Participants will undergo baseline PSMA PET/CT and dosimetry measurements during therapy to quantify the radiation dose delivered to tumors and normal tissues. Dosimetry results will be compared with biochemical (PSA) and imaging (PSMA PET/CT) responses after two treatment cycles and correlated with clinical outcomes including survival. The study aims to determine whether absorbed dose explains some cases of resistance and could inform future personalized dosing strategies.

Why it matters

Potential benefit: If successful, dosimetry could help personalize Lutetium-177 dosing so more patients receive effective treatment and fewer are exposed to ineffective or excessive radiation.

How similar studies have gone: Prior Lu-PSMA trials (VISION and LuPSMA) have shown PSA and PSMA response after treatment relate to outcomes, but using Lutetium-177 dosimetry as a predictive biomarker is relatively novel with limited prospective data.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male aged ≥18 years with adenocarcinoma of the prostate.
* Progressive metastatic prostate cancer (progression defined as two consecutive increases of PSA, or progression by bone scan or by RECIST1.1).
* Candidate for 177Lu-PSMA-RLT, with at least one lesion showing significant PSMA uptake (uptake higher than liver physiologic activity).
* Able to start treatment within four weeks of baseline PSMA PET/CT.
* Willing and able to comply with all study requirements

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.