OncoMatch/Clinical Trials/NCT07853209
A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer
Official title: A Multi-center, Open-label, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of [177Lu]Ludotadipep Treatment for Metastatic Castration-resistant Prostate Cancer
Is NCT07853209 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies [177-Lu]Ludotadipep for prostate cancer.
Treatment: [177-Lu]Ludotadipep — Primary Efficacy Endpoint \- Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first. rPFS will be analyzed using the Kaplan-Meier method. The median survival time and corresponding two-sided 95% confidence intervals (CIs) will be estimated for both the investigational and control arms, and Kaplan-Meier curves will be presented. A comparison between the investigational and control arms will be performed using a stratified Cox proportional hazards regression model. The model will be adjusted for the following stratification factors: nomogram score (≥178 vs \<178), ECOG Performance Status (0 or 1 vs 2), prior use of cabazitaxel before randomization (yes vs no), and receipt of best supportive care alone (yes vs no). The p-value will be reported. Ties in event times will be handled using the Efron method. The hazard ratio (HR) of the investigational arm relative to the control arm and its corresponding two-sided 95% confidence interval will be provided.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) overexpression (uptake greater than liver background)
PSMA-positive mCRPC confirmed by [18F]PSMA PET/CT at screening by independent central review, meeting all of the following: At least one PSMA-positive metastatic lesion. Defined as uptake greater than liver background, regardless of organ system or lesion size.
Required: PSMA (FOLH1) wild-type (no PSMA-negative lesions measurable on CT)
No PSMA-negative lesions. Defined as metastatic lesions with uptake equal to or lower than liver background and measurable on CT.
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: novel anti-androgen drug (enzalutamide, abiraterone)
At least one novel anti-androgen drug (NAAD) (e.g., enzalutamide and/or abiraterone). (First-generation anti-androgens such as bicalutamide, flutamide, and nilutamide are not counted.)
Must have received: taxane
At least one, but no more than two, prior taxane regimens. Patients who have not received docetaxel may be enrolled if deemed unsuitable, refused treatment, or lack access.
Cannot have received: PSMA-targeted radioligand therapy
Prior treatment with any of the following therapies: PSMA-targeted radioligand therapy
Lab requirements
Blood counts
Adequate bone marrow function at screening (one repeat test allowed during screening)
Kidney function
Adequate renal function at screening (one repeat test allowed during screening)
Liver function
Adequate hepatic function at screening (one repeat test allowed during screening)
Adequate bone marrow, hepatic, and renal function at screening (one repeat test allowed during screening)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07853209 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PSMA-targeted radioligand therapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 overexpression is a required biomarker for enrollment.
Does this trial require FOLH1?
Yes, FOLH1 wild-type is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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