NCT03623425

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

August 6, 2018

Last Update Submit

August 6, 2018

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of lesions characteristic for prostate cancer detected by each TEP imaging method, by 68Ga-PSMA-11 and 18F-Fluorocholine

    An experts committee will conduct a confirmatory assessment of all lesions three months after the last PET scan for each patient..

    three months after the last PET exam for each patient

Secondary Outcomes (4)

  • Count and characterize prostate cancer lesions for each method

    three months after the last PET exam for each patient

  • Number of patients whose diagnosis and/or treatment are impacted by the results of the imaging procedures

    three months after the last PET exam for each patient

  • Sensitivity, specificity and predictive values of each tomography method

    three months after the last PET exam for each patient

  • Number of adverse events and serious adverse events, whether or not related to research

    three months after the last PET exam for each patient

Study Arms (2)

68Ga-PSMA-11 PET before 18F-FCH PET

EXPERIMENTAL

Crossover design

Drug: 68Ga-PSMA-11 PETDrug: 18F-FCH PET

18F-FCH PET before 68Ga-PSMA-11 PET

EXPERIMENTAL

Crossover design

Drug: 68Ga-PSMA-11 PETDrug: 18F-FCH PET

Interventions

68Ga-PSMA-11 PETDRUG

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

18F-FCH PET before 68Ga-PSMA-11 PET68Ga-PSMA-11 PET before 18F-FCH PET
18F-FCH PETDRUG

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

18F-FCH PET before 68Ga-PSMA-11 PET68Ga-PSMA-11 PET before 18F-FCH PET

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer is an only men disease
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men ranging in age from 18 to 80
  • Patient who have developed prostate cancer, and underwent radical treatment by prostatectomy or radiotherapy.
  • Rising prostate-specific antigen (PSA) after curative treatment of prostate cancer (radical prostatectomy or radiation therapy). Following definitions will apply:
  • Biochemical recurrence =
  • After surgery: two sequential PSA values \>0.2 ng/ml
  • After radiation therapy: PSA increased by 2 ng/ml above nadir value
  • Residual disease =
  • After surgery: positive PSA immediately after surgery or positive surgical margin
  • After radiation therapy: two sequential PSA \>0.2 ng/ml (to avoid false positive)
  • Progressive disease =
  • PSA doubling time ≤ 6 months irrespective of initial PSA value
  • Patients with a positron emission tomography with 18F-Fluorocholine (PET 18F-Fcholine) requested, as part of routine care.
  • Estimated life-expectancy \> 6 months
  • Patients able to come for PET exams
  • Patients affiliated to or beneficiary of a social security plan
  • +4 more criteria

You may not qualify if:

  • Known hypersensitivity to the active substance or to any excipient of the IMP
  • Patients with known allergy to furosemide or sulfonamides. Other contraindications to furosemide do not apply to patients for whom the product will be used as a single dose
  • Patients with a history of malignant pathology (except for basal-cell cutaneous carcinoma)
  • Drug or alcohol dependence, serious current illness, mental disorder or any circumstance which, in the opinion of the investigator, could interfere with the conduct or interpretation of the study
  • Person referred in articles L.1121-7 and L.1121-8 of the Public Health Code:
  • Minor person (non-emancipated)
  • Adult person under legal protection (any form of public guardianship)
  • Adult person incapable of giving consent
  • Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de NANCY- BRABOIS

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pierre OLIVIER, MD, PhD

    CHRU de NANCY- BRABOIS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre OLIVIER, MD, PhD

CONTACT

+ 33 3 83 15 39 11p.olivier@chru-nancy.fr

Véronique ROCH, MSc

CONTACT

+33 3 83 15 42 76v.roch@chru-nancy.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Phase III, open, single center, prospective, controlled and randomized crossover study comparing diagnostic performance of 68GA-PSMA-11 and 18F-Fluorocholine. 68GA-PSMA-11 PET and 18F-Fluorocholine PET interpretation will be done by different nuclear physicians.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

February 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

August 9, 2018

Record last verified: 2018-07

Locations

FR(1)