A clinical study on 18F-PSMA-1007 PET/CT scans in patients with recurrent prostate cancer and in chronic prostate cancer

Phase 1

• Conditions: Metastatic Prostate Cancer; MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2021-000184-78-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-07
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

•Has given informed consent to participate
•Minimum age 18 years
•Can understand provided patient information material in Danish
•Verified metastatic castration resistant prostate cancer both clinically and by imaging, all degrees of dissemination included
•Life expectancy more than 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Serious medical conditions preventing treatment for prostate cancer
•Psychiatric diagnosis, or other circumstances where the will or ability to perform the planned imaging and investigations is questionable
•Known allergy for the PSMA tracer or other contents in the solution

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this project is to evaluate 18F-labelled PSMA-PET/CT imaging for response prediction and monitoring in metastatic prostate cancer;Secondary Objective: To assess the feasibility of the imaging evaluation tool PET Response Criteria in Solid Tumors (PSMA-PERCIST);Primary end point(s): Diagnostic accuracy and first detection of progression - conventional imaging compared with 18F-PSMA-PET/CT and whole body MRI (WB MRI) scans;Timepoint(s) of evaluation of this end point: Last included patients last visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Compare the imaging evaluation tools RECIST with PSMA-PERCIST in detection of first progression;Timepoint(s) of evaluation of this end point: Last included patients last visit