MedTrace Logo

F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer

NCT04239742 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-27

No results posted yet for this study

Summary

18F-PSMA-1007 is a new radiopharmaceutical for the detection of prostate cancer with potential benefits over the registered 18F-Fluciclovine (Axumin). The main potential benefit is the higher detection rate of PSMA compared to Fluciclovin in the low PSA range. It may therefore be more sensitive in detecting local disease in case of biochemical recurrens. The investigators aim to compare the detection efficacy of 18F-PSMA-1007 to 18F-Fluciclovin in prostate cancer patients with biochemical recurrence (PSA levels 0.2-5 ng/ml).

Conditions

  • Prostate Cancer Recurrent

Interventions

DIAGNOSTIC_TEST

F18-fluciclovine PET/CT

370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.

DIAGNOSTIC_TEST

F18-PSMA-1007 PET/CT

4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis

Sponsors & Collaborators

  • ABX advanced biochemical compounds GmbH

    collaborator INDUSTRY

  • Radboud Translational Medicine

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • James Nagarajah, MD, PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2022-01-31
Completion
2023-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04239742 on ClinicalTrials.gov