Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer (PROLUT)

February 28, 2025 updated by: BOURSIER Caroline, Central Hospital, Nancy, France

Comparison of Changes in Tumor Burden (Toral Tumor Volume [TMTV] and Total Lesion Activity [TLA]) in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in the Monitoring of Metastatic Castration-resistant Prostate Cancer Treated With 177Lutetium-PSMA-617

To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since few years, therapy by 177Lu-PSMA in nancy hospital began. A lot's of datas were collected. Prostate cancer is the number one killer in france and this is very important to find a diagnostic tool.

The hypothesis of this study is to demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les Nancy cedex, France, 54511
        • CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT.

Description

Inclusion Criteria:

  • patient who received a dose of 177lu-PSMA
  • patient who had imaging by 68Ga-PSMA
  • patient treated in Nancy hospital for its cancer prostate

Exclusion Criteria:

  • no social security
  • no acceptation to participating in retrospective study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient treated as part of mCPRC
All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT.
Drug: 177Lu-PSMA-617
All patients treated with 177Lu-PSMA had a post-therapy 68Ga-PSMA PET scan and a post-therapy 177Lu-PSMA-617 SPECT/CT scan. These scans are available in the CHRU PACS, and patients are informed that their data may be used for research purposes, via posters in the nuclear medicine department or via the welcome booklet,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of TMTV (total metabolic tumor volume)
Time Frame: 12 months
Measurement of TMTV (total metabolic tumor volume) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment).
12 months
Measurement of TLA (total lesion activity)
Time Frame: 12 months
Measurement of TLA (total lesion activity) on 68Ga-PSMA-11 PET/CT (pre-treatment, after 4th treatment and after 6th treatment) and on SPECT/CT (after each treatment).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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