Prognostic Value of 177Lutetium-PSMA Single Photon Emission Tomography and Timing of Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Therapy-Associated Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prognostic Value of [¹⁷⁷Lu]Lu-PSMA SPECT and Timing of RECIP Assessment in mCRPC
Overview
177Lutetium-PSMA-617 is an established treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). Early response assessment is critical for optimizing patient management. Response Evaluation Criteria in Prostate Imaging (RECIP) 1.0, initially developed for Positon Emission Tomography (PET) with 68Ga-PSMA, have demonstrated prognostic value, particularly after two treatment cycles. Recent studies suggest that SPECT at cycle 2 provides prognostic information, although it reflects only the first treatment cycle, whereas PET-based RECIP, assessed after cycle 2, captures the effect of two cycles. This study aims to evaluate the prognostic value of quantitative 177Lu-PSMA-SPECT biomarkers and determine the optimal timing for RECIP-based assessment.
Detailed description
Early response assessment is critical for optimizing patient management. Response Evaluation Criteria in Prostate Imaging (RECIP) 1.0, initially developed for Positon Emission Tomography (PET) with 68Ga-PSMA, have demonstrated prognostic value, particularly after two treatment cycles. Recent studies suggest that SPECT at cycle 2 provides prognostic information, although it reflects only the first treatment cycle, whereas PET-based RECIP, assessed after cycle 2, captures the effect of two cycles. This study aims to evaluate the prognostic value of quantitative 177Lu-PSMA-SPECT biomarkers and determine the optimal timing for RECIP-based assessment.
It would indeed be very interesting to obtain a prognostic value using imaging performed after treatment, which also provides dosimetry information to organs at risk and to the tumor and/or metastases.
Primary outcome measures
- To measure the Standardized Uptake Value of activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment [Time frame: 7 days]
- To measure of total tumor activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment [Time frame: 7 days]
- To measure the tumor volume at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- Patients with metastatic castration-resistant cancer who received at least two cycles of 177Lu-PSMA
Exclusion criteria
- Patients who refused to have their data used for research purposes
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07643935 · 2026PI123