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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Men only |
| Enrollment | 110 (estimated) |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07370597 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
- Study coordinator: Carlos Artigas, MD
- Email: carlos.artigas@hubruxelles.be
- Phone: 02.54137.81
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback
Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.
-
MRT-2359 plus apalutamide in advanced prostate cancer
This Phase 2 trial tests whether taking MRT-2359 with apalutamide can lower PSA in men with castration-resistant prostate cancer.
-
Predicting prostate cancer response to neoadjuvant darolutamide with a gene biomarker
This study tests whether a gene-based PCAI ImmunoScore can predict which high-risk localized or locally advanced prostate cancer patients will have minimal residual disease after 90–120 days of darolutamide before surgery.
-
Personal preferences for avoiding gynecomastia (Stage 1)
This project will ask men with prostate cancer and high-risk biochemical recurrence what trade-offs they'd make to avoid breast-related side effects like gynecomastia.
-
LaserSAFE: Quick in OR imaging to check margins during prostatectomy
A new in‑the‑operating‑room imaging method called LaserSAFE is tested to see if it can quickly detect cancer at the edge of the prostate during surgery for patients undergoing robot-assisted prostatectomy.
-
Early postoperative PSA after prostate removal as a predictor of cancer outcomes
We will test whether early PSA levels after prostate removal can help predict long-term cancer outcomes in men undergoing radical prostatectomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.