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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07643935
Acronym
RECIP
Enrollment
280
Registered
2026-06-12
Start date
2026-07-01
Completion date
2026-12-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapy-Associated Cancer

Brief summary

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.

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
To measure the Standardized Uptake Value of activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment7 daysAnalysis 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-treatment7 daysAnalysis of Total Tumor Activity
To measure the tumor volume at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment7 daysAnalysis of Tumor Volume

Contacts

CONTACTLaetitia IMBERT, PhD
l.imbert@chru-nancy.fr0383157879
CONTACTVeronique Roch, MSc
v.roch@chru-nancy.fr0383154276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026