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Comparison of PET With 68GA-PSMA-11 and 18F-Fluorocholine for Recurrence in Men With Prostate Cancer

NCT03623425 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-08-09

No results posted yet for this study

Summary

As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. However, choline metabolism is not increased in a significant number of cases, probably explaining why this imaging method has been reported to be weakly sensitive and specific fro the detection of prostate cancer lesions, especially at low prostate-specific antigen (PSA) levels. By contrast, prostate-specific membrane antigen (PSMA) is overexpressed in most prostate cancer, suggesting that 68Ga-labelled PSMA ligands could be superior to choline tracers. A meta-analysis published in 2016 (Perera M. and al.), which included 18 studies, of which five reported histolopathologic correlation data for 68Ga-PSMA PET-positive lesions, indicated favourable sensitivity and specificity profiles of 68Ga-labelled PSMA ligands compared to choline-based PET imaging techniques.

Conditions

Interventions

DRUG

68Ga-PSMA-11 PET

a 68GA-PSMA-11 PET exam before the a 18F-FCH PET exam

DRUG

18F-FCH PET

a 18F-FCH PET exam before the 68Ga-PSMA-11 PET exam

Sponsors & Collaborators

  • GIE NANCYCLOTEP

    collaborator OTHER

  • Advanced Nuclear Medicine Ingredients (ANMI)

    collaborator UNKNOWN

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Pierre OLIVIER, MD, PhD · CHRU de NANCY- BRABOIS

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-05-01
Completion
2020-05-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623425 on ClinicalTrials.gov