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

ABX Advanced Biochemical Compounds

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer Recurrent; Prostate Cancer

Treatments: Drug: F-18-Fluorocholine; Drug: F-18-PSMA-1007

Study type: Interventional

Funder types: Industry

Identifiers

NCT04102553

ABX-CT-301

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

F-18-PSMA-1007

Experimental group

Description:

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

Treatment:

Drug: F-18-Fluorocholine

Drug: F-18-PSMA-1007

F-18-Fluorocholine

Active Comparator group

Description:

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

Treatment:

Drug: F-18-Fluorocholine

Drug: F-18-PSMA-1007