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NCT06461689 Clinical Trial

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

Prostate Cancer Metastatic Clinical Trial

— PROLUT  

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06461689
Other study ID # 2024PI106
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date March 1, 2026

Study information
Verified date June 2024
Source Central Hospital, Nancy, France
Contact Caroline Boursier, MD
Phone +33383154276
Email c.boursier@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date March 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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,

Locations
Country Name City State
France CHRU de NANCY Vandoeuvre les Nancy cedex

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of TMTV (total metabolic tumor volume) 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
Primary Measurement of TLA (total lesion activity) 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
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