NCT03344822

Brief Summary

Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET. The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.

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
33

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2 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

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 14, 2017

Last Update Submit

November 15, 2017

Conditions

Prostate Cancer

Keywords

68Ga-PSMA PET

Outcome Measures

Primary Outcomes (1)

  • percentage of modification of management intent

    modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT

    1 month

Study Arms (1)

68Ga-PSMA PET-CT

EXPERIMENTAL
Diagnostic Test: 68Ga-PSMA-11Diagnostic Test: 18F-Choline PET-CT

Interventions

68Ga-PSMA-11DIAGNOSTIC_TEST

radioactive tracer for PET-CT (68Ga-PSMA-11)

68Ga-PSMA PET-CT
18F-Choline PET-CTDIAGNOSTIC_TEST

radioactive tracer for PET-CT (18F-Choline PET-CT)

68Ga-PSMA PET-CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline

You may not qualify if:

  • contraindication of 68Ga-PSMA PET-CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central hospital Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
Even if the study has only one arm, the results of both PET imageries will be blind assessed.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Each patient will realize a 18F-Choline PET/CT then a 68Ga-PSMA-11 PET/CT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

January 2, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)