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

Prostate Cancer Clinical Trial

Official title:

Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102553
• Other study ID #: ABX-CT-301
• Status: Completed
• Phase: Phase 3
• Start date: March 6, 2019
• Est. completion date: March 19, 2021

Study information

• Verified date: June 2021
• Source: ABX advanced biochemical compounds GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 19, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

Intervention

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

Locations

Country	Name	City	State
France	Centre Jean Perrin Clermont-Ferrand	Clermont-Ferrand
France	Centre Léon Bérard LUMEN	Lyon
France	Hôpitaux de Brabois (Vandoeuvre-les-Nancy)	Nancy
France	Hôpital Européen Georges-Pompidou	Paris
France	Hôpital Tenon	Paris
France	Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
ABX advanced biochemical compounds GmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine		Within 6 months after PET/CT