NCT06461689

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

June 5, 2024

Last Update Submit

February 28, 2025

Conditions

Prostate Cancer Metastatic

Keywords

prostate cancertheragnostic

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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

Interventions

177Lu-PSMA-617DRUG

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,

patient treated as part of mCPRC

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pluvicto

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

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

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 17, 2024

Study Start

December 31, 2024

Primary Completion

February 1, 2025

Study Completion

February 28, 2025

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations

FR(1)