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OpenTrials
Completed

NCT Number: NCT06461689

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

177Lu-PSMA-617

Drug

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,

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: PROLUT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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