Trial | NCT04102553  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
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.
Study Started
Mar 06
2019
Primary Completion
Oct 30
2020
Study Completion
Mar 19
2021
Last Update
Jun 29
2021

Drug F-18-PSMA-1007

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

Drug F-18-Fluorocholine

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

F-18-PSMA-1007 Experimental

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

F-18-Fluorocholine Active Comparator

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

Criteria 

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
No Results Posted