Actively Recruiting
LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.
Led by Jules Bordet Institute · Updated on 2026-01-27
110
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A substantial proportion of patients with mCRPC do not respond to 177Lu-PSMA-RLT. The PSA response to Lu-PSMA was observed in nearly 46% of patients included in VISION trial and 66% in LuPSMA trial (4,5). The response to treatment can be evaluated after two cycles using the PSA or PSMA PET/CT scan. Gafita et al. Data have shown that PSA and PSMA perform equally in assessing response to 177Lu-PSMA treatment, and their changes after two cycles are related to patient survival. After two cycles, patients with no PSA or PSMA response had worse outcomes than those with partial response or stable disease . That means PSA and PSMA changes after two cycles can be used as a surrogate of patient outcome. However, the explanation of disease resistance to 177Lu-PSMA-RLT is not yet fully understood. Inappropriate dose administration might be one of the possible explanations. A dose-response relationship has been established in radiotherapy , making dosimetry a standard of care in conventional radiotherapy. In the radionuclide therapy settings, the dose-response relationship has been reported in a multi-center phase 2 trial on the selective internal radiotherapy in hepatocellular carcinoma. In this context, calculating the absorbed dose to tumour lesions could be an excellent method to individualize radionuclide therapy to achieve a maximal response to treatment. If dosimetry calculations could predict which patients would ultimately respond or not respond to treatment, administered dose and number of 177Lu-PSMA-RLT cycles could be adapted early during the treatment course. In this context, our study aims to analyze if absorbed tumour dose obtained by dosimetry calculations could be used as a biomarker to predict non-response to treatment early after one cycle, as the first step towards treatment dose adaptation of a personalized radionuclide treatment approach.
CONDITIONS
Official Title
LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 60 years or older with adenocarcinoma of the prostate
- Progressive metastatic prostate cancer defined by two consecutive PSA increases or progression by bone scan or RECIST1.1 criteria
- Candidate for 177Lu-PSMA radioligand therapy with at least one lesion showing PSMA uptake higher than liver physiologic activity
- Able to start treatment within four weeks after baseline PSMA PET/CT
- Willing and able to comply with all study requirements
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
Research Team
C
Carlos Artigas, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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