Lutetium-177 dosimetry to predict response to PSMA radioligand therapy in metastatic prostate cancer
LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Sex | Male |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07370597 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brussels
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Carlos Artigas, MD
- Email: carlos.artigas@hubruxelles.be
- Phone: 02.54137.81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.