F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence (NCT04102553) | Clinical Trial Compass
CompletedPhase 3
F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
France200 participantsStarted 2019-03-06
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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
What they're measuring
1
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine