NCT04102553

Brief Summary

This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach
1 country

6 active sites

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

Study Start

First participant enrolled

March 6, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

September 24, 2019

Last Update Submit

June 28, 2021

Conditions

Prostate CancerProstate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

  • To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine

    Within 6 months after PET/CT

Study Arms (2)

F-18-PSMA-1007

EXPERIMENTAL

Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT.

Drug: F-18-PSMA-1007Drug: F-18-Fluorocholine

F-18-Fluorocholine

ACTIVE COMPARATOR

Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT.

Drug: F-18-PSMA-1007Drug: F-18-Fluorocholine

Interventions

F-18-PSMA-1007DRUG

Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.

F-18-FluorocholineF-18-PSMA-1007
F-18-FluorocholineDRUG

Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.

F-18-FluorocholineF-18-PSMA-1007

Eligibility Criteria

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

You may qualify if:

  • male with original diagnosis of prostate carcinoma with prior definitive therapy
  • suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
  • life expectancy of 6 months or more as judged by the investigator
  • willing and able to undergo all study procedures
  • informed consent in writing (dated and signed)

You may not qualify if:

  • age: less than18 years
  • contraindications for F-18-Fluorocholine
  • contraindications for any of the ingredients of F-18-PSMA-1007
  • close affiliation with the investigational site; e.g. first-degree relative of the investigator
  • at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
  • having been previously enrolled in this clinical trial
  • mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
  • being clinically unstable or requiring emergency treatment
  • being considered a vulnerable person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Jean Perrin Clermont-Ferrand

Clermont-Ferrand, France

Location

Centre Léon Bérard LUMEN

Lyon, France

Location

Hôpitaux de Brabois (Vandoeuvre-les-Nancy)

Nancy, France

Location

Hôpital Européen Georges-Pompidou

Paris, France

Location

Hôpital Tenon

Paris, France

Location

Hospices Civils de Lyon

Pierre-Bénite, France

Location

Related Publications (1)

  • Olivier P, Giraudet AL, Skanjeti A, Merlin C, Weinmann P, Rudolph I, Hoepping A, Gauthe M. Phase III Study of 18F-PSMA-1007 Versus 18F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study. J Nucl Med. 2023 Apr;64(4):579-585. doi: 10.2967/jnumed.122.264743. Epub 2022 Nov 23.

    PMID: 36418170DERIVED

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 25, 2019

Study Start

March 6, 2019

Primary Completion

October 30, 2020

Study Completion

March 19, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations

FR(6)