Prognostic Value of 177Lutetium-PSMA Single Photon Emission Tomography and Timing of Response

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.

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Key information

Conditions

Therapy-Associated Cancer Neoplasms Neoplasms, Second Primary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Analysis of Standardized Uptake value
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

Analysis of Total Tumor Activity
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

Analysis of Tumor Volume

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia IMBERT, PhD

CONTACT

[email protected]

0383157879 ext. +33

Veronique Roch, MSc

CONTACT

[email protected]

0383154276 ext. +33

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Prognostic Value of [¹⁷⁷Lu]Lu-PSMA SPECT and Timing of RECIP Assessment in mCRPC

Acronym: RECIP

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 12, 2026
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed