NCT07643935

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

May 6, 2026

Last Update Submit

June 10, 2026

Conditions

Therapy-Associated Cancer

Outcome Measures

Primary Outcomes (3)

  • To measure the Standardized Uptake Value of activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment

    Analysis of Standardized Uptake value

    7 days

  • To measure of total tumor activity at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment

    Analysis of Total Tumor Activity

    7 days

  • To measure the tumor volume at the tumor lesion on 177Lu-PSMA-SPECT for the pronostic value of scintigraphy post-treatment

    Analysis of Tumor Volume

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metastatic castration-resistant cancer who received at least two cycles of 177Lu-PSMA

You may qualify if:

  • Patients with metastatic castration-resistant cancer who received at least two cycles of 177Lu-PSMA

You may not qualify if:

  • Patients who refused to have their data used for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms

Central Study Contacts

Laetitia IMBERT, PhD

CONTACT

0383157879l.imbert@chru-nancy.fr

Veronique Roch, MSc

CONTACT

0383154276v.roch@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

May 6, 2026

First Posted

June 12, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06