Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer (PROLUT)
June 23, 2026 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
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Vandœuvre-lès-Nancy, France, 54511
- CHRU de Nancy
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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 |
|---|---|
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patient treated as part of mCPRC
All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT.
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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,
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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
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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).
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12 months
|
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Measurement of TLA (total lesion activity)
Time Frame: 12 months
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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).
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
June 25, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
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
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