NCT07370597 LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.
| NCT ID | NCT07370597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jules Bordet Institute |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2026-02-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07370597 clinical trial?
This trial is open to male participants only, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07370597 currently recruiting?
Yes, NCT07370597 is actively recruiting participants. Contact the research team at carlos.artigas@hubruxelles.be for enrollment information.
Where is the NCT07370597 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT07370597 clinical trial?
NCT07370597 is sponsored by Jules Bordet Institute. The trial plans to enroll 110 participants.
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