F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence

Phase 3

Completed

• Conditions: Prostate Cancer Recurrent; Prostate Cancer
• Interventions: Drug: F-18-PSMA-1007; Drug: F-18-Fluorocholine

• Registration Number: NCT04102553
• Lead Sponsor: ABX advanced biochemical compounds GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Primary Completion: 2020-10-30
• Study Completion: 2021-03-19
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine	Within 6 months after PET/CT

Trial Locations

Locations (6)

Centre Jean Perrin Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpitaux de Brabois (Vandoeuvre-les-Nancy); 🇫🇷 Nancy, France

Centre Léon Bérard LUMEN; 🇫🇷 Lyon, France

Hôpital Tenon; 🇫🇷 Paris, France

Hôpital Européen Georges-Pompidou; 🇫🇷 Paris, France

Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France