Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes baseline and post-therapy data to identify biomarkers that predict PSA response and progression-free survival in patients receiving Lu-177 PSMA-617 (Pluvicto). Participants receive up to six treatments as part of standard care and undergo PSMA PET/CT imaging and post-therapy dosimetry alongside blood-based measurements. The research combines diagnostic imaging, post-therapy dosimetry, and molecular markers to build a predictive model of treatment response. The study does not change the approved treatment plan and uses data from routine clinical care. Both prospective and retrospective components may be included, with informed consent obtained where required.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Histologically confirmed prostate adenocarcinoma
* Progressive, PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) for which \[177Lu\]Lu-PSMA-617 (Pluvicto) radioligand therapy has been given or is planned, according to the approved Summary of Product Characteristics (previous treatment with an androgen receptor pathway inhibitor and taxane-based chemotherapy)
* PSMA positivity confirmed on diagnostic \[68Ga\]Ga-PSMA-11 PET/CT before the start of treatment, defined as at least one tumor lesion with uptake higher than in normal liver
* For the prospective part: signed informed consent. For the retrospective part: ethics committee waiver of the requirement to obtain informed consent

Exclusion Criteria:

* Contraindications to \[177Lu\]Lu-PSMA-617 (Pluvicto) therapy according to the Summary of Product Characteristics
* No PSMA-positive lesions on diagnostic PSMA PET/CT
* Diagnostic PSMA PET/CT not performed with \[68Ga\]Ga-PSMA-11, or not available for quantitative analysis (original images not saved or not accessible)
* Another active malignancy (except non-melanoma skin cancer or a clinically insignificant tumor) that could affect the assessment of survival
* Refusal to participate in the study (for the prospective part: informed consent not signed)

Where it's running

• Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Nuclear Medicine
  Kaunas, Lithuania Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.