Tests imaging markers during lutetium PSMA treatment in advanced prostate cancer
Studies scan images to track response in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer
Key facts
- Where
- Grenoble, FranceSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. They are starting [177Lu]Lu-PSMA treatment.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Proven prostate adenocarcinoma; progressive metastatic castration-resistant prostate cancer
- Earlier treatment
- Disease worsened on, or the man could not tolerate, a newer anti-androgen drug (abiraterone, enzalutamide, apalutamide or darolutamide). Also at least one taxane chemotherapy, or symptoms with chemotherapy judged unsuitable.
Main reasons for not taking part
- Patient opposed to the use of his data for clinical research
Read by machine on 12 November 2026.
Where in France
- CHU Grenoble AlpesGrenoble, FranceContact: Loïc DJAÏLEB, PU-PHTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT06828263
- Record updated
- 26 December 2025
- Original description
Lutetium-177 (177Lu) prostate-specific membrane antigen (177Lu-PSMA) is a radiolabelled small-molecule inhibitor that binds with high affinity to PSMA and delivers β particle radiation. [177Lu]Lu-PSMA-617 (Pluvicto) was approved by the U.S. Food and Drug administration (FDA) in patients with late-stage, PSMA positive metastatic castration-resistant prostate cancer (mCRPC) based on the results from the phase 3 VISION trial [1].Read full original descriptionShow less
Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer
Lutetium-177 (177Lu) prostate-specific membrane antigen (177Lu-PSMA) is a radiolabelled small-molecule inhibitor that binds with high affinity to PSMA and delivers β particle radiation. [177Lu]Lu-PSMA-617 (Pluvicto) was approved by the U.S. Food and Drug administration (FDA) in patients with late-stage, PSMA positive metastatic castration-resistant prostate cancer (mCRPC) based on the results from the phase 3 VISION trial [1].
Early identification of tumor progression may reduce unnecessary therapy cycles and their associated risk of adverse events as well as reducing costs and improving patient care by initiating an earlier change in treatment towards a possibly more efficacious therapy.
Response Evaluation Criteria In PSMA-imaging (RECIP) version 1.0 is an evidence-based framework to evaluate therapeutic efficacy in metastatic prostate cancer using PSMA-imaging[2,3]. Interim PSMA-PET/CT by RECIP 1.0 criteria performed at 10 weeks after two cycles of PSMA theranostics ([177Lu]Lu-PSMA- 617 or [177Lu]Lu-PSMA-I\&T) is prognostic for overall survival[2]. RECIP 1.0 criteria were validated based on overall survival outcome for measuring response in metastatic prostate cancer during androgen receptor-signaling inhibitors[4], as well as in early-stage prostate cancer in patients with biochemical recurrence after initial therapy[5].
Lutetium-177 is a beta therapy that also emits 11% gamma rays, which can be utilised to derive whole-body tomographic images similar to PSMA-PET/CT. Serial Lutetium-177 PSMA-targeted single photon emission tomography/computed tomography [177Lu]Lu-PSMA-SPECT/CT henceforth referred to as LuPSMASPECT/ CT has potential as an imaging response biomarker for 177Lu-PSMA therapy. This principle enables image quantitation and evaluation after every treatment dose. SPECT/CT post [177Lu]Lu-PSMA administration represents a potentially cost-effective alternative to interim PSMA-PET/CT.
Preliminary results have shown a good correlation between changes in LuPSMASPECT/ CT during PSMA theranostics and clinical outcome. LuPSMA-SPECT/CT can provide effective response information as early as 6 weeks after initiation of [177Lu]Lu-PSMA-I\&T, i.e. any increase in total tumor volume on SPECT/CT imaging was associated with shorter PSA-PFS (median: 3.7 vs 6.7 months; HR, 2.5; 95% CI 1.5-4.2; p<0.001)[6]. Changes in total tumor volume on 12-week LuPSMASPECT/ CT were also found to be correlated with progression-free survival after [177Lu]Lu-PSMA-I\&T[7].
The growing evidence suggesting that LuPSMA-SPECT/CT is a new, early surrogate marker for assessing response to treatment has several potential upsides, including the potential replacement of interim PSMA-PET/CT, therefore costsaving, radiation exposure-saving, and SPECT/CT imaging being more convenient and widely available.
Given that data regarding SPECT/CT-based treatment response monitoring during PSMA theranostics are limited, this study aims to prospectively investigate the role of LuPSMA-SPECT/CT imaging for response evaluation during treatment with [177Lu]Lu-PSMA in mCRPC patients.
Inclusion: Adult aged 18 or older with proven adenocarcinoma of the prostate; Diagnosis of progressive metastatic castration-resistant prostate cancer; Progression or intolerance on a novel anti-androgen therapy (i.e. abiraterone, enzalutamide, apalutamide or darolutamide); Prior therapy with at least one taxane-based chemotherapy during the course of prostate cancer or the patient is symptomatic and assessed as unfit for chemotherapy; ECOG Performance status 0 to 2.
Exclusion: Patient opposed to the use of his data for clinical research.