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

• Status: Completed
• Trial end date: 2021-03-19
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ABX advanced biochemical compounds GmbH
• Treatments: Choline

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